Like many other biopharmas taking on the diabetes market, Biodel (BIOD) has had pretty serious setbacks. The decision to abandon the original Linjeta absolutely hammered the stock, and it is true that the company is a very speculative stock at this point. That said, with a near-term glucagon program that has relatively lower clinical risk and multiple attempts at the insulin market still in hand, it may be premature to completely close the book on this stock.
Can Glucagon Fill A Gap?
Biodel's nearest-term opportunity is with its glucagon rescue program. Glucagon is a naturally-occurring hormone produced by the pancreas to raise blood glucose levels. In healthy individuals, this is part of the normal blood glucose regulation process.
Read the full piece here:
Biodel Back At Square One, Not Zero
Showing posts with label Biodel. Show all posts
Showing posts with label Biodel. Show all posts
Thursday, April 12, 2012
Friday, July 8, 2011
Generex - Seriously?
I'm halfway surprised that Generex (Nasdaq: GNBT.OB) can still get anybody to listen to them. But I guess hope dies hard.
The company says that it has results from two "major" Phase 1 studies of Oral-lyn that ...
You know what? Forget it.
I'm not going to give this garbage pile any more of my time. Oral-lyn has been junk from day one and the notion that there is such a thing as a "major" Phase 1 study just proves all over again that this is a company that exists to suck up the capital of credulous retail investors.
Want to invest in a risky diabetes play? Go with Biodel (Nasdaq: BIOD) or MannKind (Nasdaq: MNKD). Go with Amylin (Nasdaq: AMLN), Novo Nordisk (NYSE: NVO), Insulet (Nasdaq: PODD) or DexCom (Nasdaq: DXCM) for something a little more tangible. Hell, take a flyer on Lexicon (Nasdaq: LXRX) and its early-stage diabetes compound.
But for god's sake, don't give Generex any more attention.
Disclosure: I own shares of Amylin and Lexicon
The company says that it has results from two "major" Phase 1 studies of Oral-lyn that ...
You know what? Forget it.
I'm not going to give this garbage pile any more of my time. Oral-lyn has been junk from day one and the notion that there is such a thing as a "major" Phase 1 study just proves all over again that this is a company that exists to suck up the capital of credulous retail investors.
Want to invest in a risky diabetes play? Go with Biodel (Nasdaq: BIOD) or MannKind (Nasdaq: MNKD). Go with Amylin (Nasdaq: AMLN), Novo Nordisk (NYSE: NVO), Insulet (Nasdaq: PODD) or DexCom (Nasdaq: DXCM) for something a little more tangible. Hell, take a flyer on Lexicon (Nasdaq: LXRX) and its early-stage diabetes compound.
But for god's sake, don't give Generex any more attention.
Disclosure: I own shares of Amylin and Lexicon
Tuesday, May 3, 2011
Investopedia: Novo Nordisk Still One Of The Best Around
Is Novo Nordisk (NYSE:NVO) a full-fledged pharmaceutical company, or does it fall into that "specialty pharmaceutical" niche? Will the company succeed in expanding beyond diabetes and very specialized hormone/protein therapies? Does anybody care so long as the company delivers double-digit revenue growth and returns on capital that approach 40%?
The Strong Get Stronger in Q1
While some analysts seem to be fretting a bit about a "slowdown" in the insulin business for Novo Nordisk, the fact remains that this is one of the fastest-growing major pharmaceutical companies on the planet. Total revenue rose 15% this quarter, with the diabetes franchise growing 16% and the biopharmaceuticals business up 10%. Within diabetes, insulins grew 8% due to continued growth of the analog platform, while Victoza showed nearly 200% growth and delivered over $200 million in revenue on its way to blockbuster status.
Profitability also improved this quarter. Gross margin slid a bit as the company could not completely offset a drag from foreign currency, but the loss was limited to 20 basis points. Operating income grew 24%, though, as sales, administrative and R&D expenses all grew by mid-single-digit amounts. Although the R&D spend looked a bit light this quarter, it looks like more of a timing issue than any sort of philosophical change.
To read the full article, please follow this link:
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Wednesday, March 9, 2011
Investopedia: DexCom Shows Diabetes Still A Growth Industry
Today's diabetes market highlights the importance that individual stock selection still has in successful investing. While it may very well be generally true that overall sector movements explain a lot of an individual stock's performance, that has not been the case in this market. While the overall tone and tenor has been pretty negative, select names like Novo Nordisk (NYSE:NVO) and DexCom (Nasdaq:DXCM) have done quite well indeed.
A Strong End to DexCom's Year
It has not all been smooth sailing for DexCom (the stock took a spanking late in 2010), but the company continues to build its emerging continuous glucose monitoring business. For the fourth quarter, total revenue increased 49%, while product revenue more than doubled from the year-ago level and rose 26% sequentially. DexCom also saw an encouraging jump in the sale of its start kits, to the tune of 24% sequential growth.
As the company increases its sales, it is beginning to see some operating leverage. Gross profit on product sales increased nearly five times (again, on a doubling of revenue) in the fourth quarter, when compared to the prior year. At the same time, the company has kept a lid on SG&A spending while still investing significant resources into R&D. All told, the company produced an operating loss more or less in line with the prior year's level.
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http://stocks.investopedia.
A Strong End to DexCom's Year
It has not all been smooth sailing for DexCom (the stock took a spanking late in 2010), but the company continues to build its emerging continuous glucose monitoring business. For the fourth quarter, total revenue increased 49%, while product revenue more than doubled from the year-ago level and rose 26% sequentially. DexCom also saw an encouraging jump in the sale of its start kits, to the tune of 24% sequential growth.
As the company increases its sales, it is beginning to see some operating leverage. Gross profit on product sales increased nearly five times (again, on a doubling of revenue) in the fourth quarter, when compared to the prior year. At the same time, the company has kept a lid on SG&A spending while still investing significant resources into R&D. All told, the company produced an operating loss more or less in line with the prior year's level.
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Thursday, February 3, 2011
What Is Biodel Doing?
If I'm understanding this right, Biodel (Nasdaq: BIOD) has decided to basically abandon the supposedly-ready-for-market version of Linjeta and is more or less going back to the drawing board. More specifically, the company is going to work on some alternative formulations of Linjeta with an eye towards starting a Phase 2 study in 2012.
Now, that's a big surprise to me. Biodel got rejected by the FDA supposedly because some samples were contaminated/altered by poor packaging and storage and that messed up the total data package. Supposedly, if those tainted results were removed from the data package, it was an effective, safe, and approvable product.
If that were true, why is the company just chucking that formulation and setting the time-to-market clock back at least five years? If the version of Linjeta that they filed an NDA for actually worked, why aren't they running another Phase 3 and looking to get that on the market?
Although the company doesn't have the money to do a Phase 3 without another capital raise, it takes even more capital to go all the way back to Phase 2 and work back towards another NDA. Not surprisingly, though, the company is also putting its other R&D programs on ice including a basal insulin and the VIAtab sublingual version (which I never thought had much hope anyway...).
All in all, a very curious set of moves in my view. Given that I'm not sure what exactly this means about the real quality of Linjeta, the real issues with the NDA, and the implications that all has on management integrity and believability, I'd be very cautious with this stock.
Now, that's a big surprise to me. Biodel got rejected by the FDA supposedly because some samples were contaminated/altered by poor packaging and storage and that messed up the total data package. Supposedly, if those tainted results were removed from the data package, it was an effective, safe, and approvable product.
If that were true, why is the company just chucking that formulation and setting the time-to-market clock back at least five years? If the version of Linjeta that they filed an NDA for actually worked, why aren't they running another Phase 3 and looking to get that on the market?
Although the company doesn't have the money to do a Phase 3 without another capital raise, it takes even more capital to go all the way back to Phase 2 and work back towards another NDA. Not surprisingly, though, the company is also putting its other R&D programs on ice including a basal insulin and the VIAtab sublingual version (which I never thought had much hope anyway...).
All in all, a very curious set of moves in my view. Given that I'm not sure what exactly this means about the real quality of Linjeta, the real issues with the NDA, and the implications that all has on management integrity and believability, I'd be very cautious with this stock.
Monday, January 31, 2011
Investopedia: A Foursome Of Pharma Earnings Suggests Business Is Still Tough
Medical progress is a tricky thing, especially since the pace of that progress follows no particular rule or trajectory. Pharmaceutical companies increasingly find that they must spend considerably more money on R&D only to develop drugs that are incrementally better than generics that have been available for two decades. Add to that fierce global competition, occasionally hostile regulator behavior and opportunistic generic drug developers laying in wait, and it is not altogether surprising to see a mixed bag as pharmaceutical companies report their fourth quarter results.
AstraZeneca - Sharing the Wealth, But Taking Some Blows
AstraZeneca did a little better than expected, but sales were still down about 4% in the fourth quarter. The company's largest drugs had mixed performance, as Crestor sales jumped 26% and Nexium sales fell 2%. Investors should note, though, that just four drugs accounted for 57% of revenue and AstaZeneca is one of the most "concentrated" drug companies out there. (For more, see UK's Global Footprint Stocks.)
AstraZeneca has had some rough going of late including a complete response letter for Brillinta and the decision to discontinue a range of drugs including olaparib, Certriad, and Iressa. On a more positive note, the company is moving ahead with an exciting first-of-its-kind oral diabetes drug, as well as an oral rheumatoid arthritis drug that could threaten large franchises of Abbott Labs (NYSE:ABT) and Roche (Nasdaq:RHHBY).
On a happier note, AstraZeneca is not being miserly with its wealth - the company doubled its buyback to $4 billion and pays a respectable dividend. Investors may question, though, whether that money would be better spent in the lab, as pipeline disappointments have taken more than $1 billion out of the mid-term revenue outlook.
Please follow this link to the full article:
http://stocks.investopedia.
AstraZeneca - Sharing the Wealth, But Taking Some Blows
AstraZeneca did a little better than expected, but sales were still down about 4% in the fourth quarter. The company's largest drugs had mixed performance, as Crestor sales jumped 26% and Nexium sales fell 2%. Investors should note, though, that just four drugs accounted for 57% of revenue and AstaZeneca is one of the most "concentrated" drug companies out there. (For more, see UK's Global Footprint Stocks.)
AstraZeneca has had some rough going of late including a complete response letter for Brillinta and the decision to discontinue a range of drugs including olaparib, Certriad, and Iressa. On a more positive note, the company is moving ahead with an exciting first-of-its-kind oral diabetes drug, as well as an oral rheumatoid arthritis drug that could threaten large franchises of Abbott Labs (NYSE:ABT) and Roche (Nasdaq:RHHBY).
On a happier note, AstraZeneca is not being miserly with its wealth - the company doubled its buyback to $4 billion and pays a respectable dividend. Investors may question, though, whether that money would be better spent in the lab, as pipeline disappointments have taken more than $1 billion out of the mid-term revenue outlook.
Please follow this link to the full article:
http://stocks.investopedia.
Thursday, January 20, 2011
Investopedia: MannKind And The FDA - Here We Go Again
Yet another company has fallen into the purgatory that is the FDA Complete Response Letter (CRL) cycle. While it was not altogether unexpected that MannKind (Nasdaq:MNKD) would get another CRL from the FDA (which is tantamount to a rejection), this nitpicky rejection from the agency will likely set the company back at least another year in its attempt to get inhaled insulin to the market and in the hands of diabetics.
The Latest Developments
On Wednesday afternoon, MannKind announced that the FDA had sent the company a CRL for its most recent re-application for its Afrezza inhaled insulin. This time the FDA's concerns were about potential differences between the MedTone inhaler used in past pivotal studies and the next-generation device that the company intends to actually launch with approval.
The FDA has now determined that the company needs to run at least two additional new studies (one in Type 1 diabetics and one in Type 2 diabetics) to determine if all of the relevant data is equivalent between the two devices. The FDA also wants at least one arm of one of the studies to include patients using the older MedTone device so that there can be head-to-head comparisons. (For related reading, check out The Curious And Complicated Case Of MannKind.)
To some extent, this is a legitimate request from the FDA. It is fair for the agency to want to confirm that the two devices work in basically the same fashion and produce the same outcomes in patients. Moreover, the FDA's request that the study include at least 12 weeks of consistent use (after a titration period) is not terribly onerous either - after all, diabetes drug studies often run at least a year, and the FDA increasingly seems to be demanding a minimum of two years of data.
In addition to the head-to-head comparison, the FDA wants more mundane data like information on the new device, updated safety information and so forth. (For more, see Dark Days In Diabetes.)
Please follow the link for the full article:
http://stocks.investopedia.
The Latest Developments
On Wednesday afternoon, MannKind announced that the FDA had sent the company a CRL for its most recent re-application for its Afrezza inhaled insulin. This time the FDA's concerns were about potential differences between the MedTone inhaler used in past pivotal studies and the next-generation device that the company intends to actually launch with approval.
The FDA has now determined that the company needs to run at least two additional new studies (one in Type 1 diabetics and one in Type 2 diabetics) to determine if all of the relevant data is equivalent between the two devices. The FDA also wants at least one arm of one of the studies to include patients using the older MedTone device so that there can be head-to-head comparisons. (For related reading, check out The Curious And Complicated Case Of MannKind.)
To some extent, this is a legitimate request from the FDA. It is fair for the agency to want to confirm that the two devices work in basically the same fashion and produce the same outcomes in patients. Moreover, the FDA's request that the study include at least 12 weeks of consistent use (after a titration period) is not terribly onerous either - after all, diabetes drug studies often run at least a year, and the FDA increasingly seems to be demanding a minimum of two years of data.
In addition to the head-to-head comparison, the FDA wants more mundane data like information on the new device, updated safety information and so forth. (For more, see Dark Days In Diabetes.)
Please follow the link for the full article:
http://stocks.investopedia.
Wednesday, December 15, 2010
The Curious and Complicated Case of MannKind
Sometimes it is not always best to be first, sometimes it is better to let others go first and play the role on unwitting minesweeper. That is certainly what investors in MannKind (Nasdaq:MNKD) are hoping as this company approaches a critical FDA decision date (December 29) for its inhaled insulin product. While prior attempts at inhaled insulin have gone down in flames, MannKind may be in a position to learn from these mistakes and prosper where others have failed.
A Different Inhaled Insulin
There seems to be almost a knee-jerk need to compare MannKind's Afrezza (also spelled AFREZZA) to the failed inhaled insulin product developed and marketed by Pfizer (NYSE:PFE) and Nektar (Nasdaq:NKTR) known as Exubera. Exubera was a high-profile $2 billion failure for Pfizer, and this failure was followed quickly by the abandonment of inhaled insulin programs at Lilly (NYSE:LLY) and Novo Nordisk (NYSE:NVO).
Afrezza is a different product, though. Exubera was in most respects just an inhalable alternative to injected rapid-acting insulins like Sanofi-aventis' (NYSE:SNY) Apidra, Lilly's Humalog or Novo's NovoRapid. While these insulins have a peak of activity around 60 minutes after administration, Exubera peaked around 49 minutes. By comparison, Afrezza peaks in just 12-14 minutes, much more closely mimicking natural post-meal insulin secretion from a healthy pancreas.
Please follow this link for the full piece:
http://stocks.investopedia.
A Different Inhaled Insulin
There seems to be almost a knee-jerk need to compare MannKind's Afrezza (also spelled AFREZZA) to the failed inhaled insulin product developed and marketed by Pfizer (NYSE:PFE) and Nektar (Nasdaq:NKTR) known as Exubera. Exubera was a high-profile $2 billion failure for Pfizer, and this failure was followed quickly by the abandonment of inhaled insulin programs at Lilly (NYSE:LLY) and Novo Nordisk (NYSE:NVO).
Afrezza is a different product, though. Exubera was in most respects just an inhalable alternative to injected rapid-acting insulins like Sanofi-aventis' (NYSE:SNY) Apidra, Lilly's Humalog or Novo's NovoRapid. While these insulins have a peak of activity around 60 minutes after administration, Exubera peaked around 49 minutes. By comparison, Afrezza peaks in just 12-14 minutes, much more closely mimicking natural post-meal insulin secretion from a healthy pancreas.
Please follow this link for the full piece:
http://stocks.investopedia.
Friday, December 3, 2010
Merck Makes A Smart Buy
Large pharmaceuticals buy small private companies all the time, often paying so little that they are not even obligated to report the transactions to shareholders. With Merck's (NYSE: MRK) deal to buy SmartCells, though, things are a little different on two levels. Not only is the purchase price large enough to get some attention, but the technology could be a real game-changer down the road.
The Deal
Rumors had been creeping around for a little while on this deal, but Merck made it official Thursday morning that it was acquiring SmartCells in an all-cash deal. Although the companies did not discuss the upfront payment, it is a comprehensive deal that includes potential milestones and follow-on payments that could all total in excess of $500 million. Given the size of the transaction and the timing of the payments, I am not sure that Merck will have to file an 8-K for this, so investors may be hard-pressed to find more details on the transaction. (For more, see The Wacky World Of Mergers And Acquisitions.)
Please click below for the full piece:
http://stocks.investopedia.
The Deal
Rumors had been creeping around for a little while on this deal, but Merck made it official Thursday morning that it was acquiring SmartCells in an all-cash deal. Although the companies did not discuss the upfront payment, it is a comprehensive deal that includes potential milestones and follow-on payments that could all total in excess of $500 million. Given the size of the transaction and the timing of the payments, I am not sure that Merck will have to file an 8-K for this, so investors may be hard-pressed to find more details on the transaction. (For more, see The Wacky World Of Mergers And Acquisitions.)
Please click below for the full piece:
http://stocks.investopedia.
Tuesday, November 9, 2010
Dark Days In Diabetes
Diabetes has long been one of the most "investable" diseases, with a host of pharmaceutical, biotech, and medical device plays on this serious (and increasingly common) condition. Recent weeks have not been kind to the sector, though, as a range of problems and challenges have sent investors to the sidelines.
FDA - Don't Call Us, We'll Call You
Several companies have seen their fortunes take a bad turn either in the clinic or from the Food and Drug Administration.
Roche (Nasdaq:RHHBY) has essentially been sent back to the drawing board on its weekly GLP-1 drug taspoglutide, and there is a good chance that the side-effect problems that halted a Phase 3 study will prove insurmountable. Another would-be long-acting GLP-1 drug (to be marketed by Eli Lilly (NYSE:LLY) was surprisingly rejected due to FDA worries about safety and a demand for a new study.
Biodel (Nasdaq:BIOD) recently saw its application for a new formulation of insulin rejected due to sample handling and patient drop-out problems, and the FDA's unwillingness to brook a post-hoc analysis of the data. Both Vivus (Nasdaq:VVUS) and Arena Pharmaceuticals (Nasdaq:ARNA) saw their obesity drugs rejected (obesity is a leading cause of Type 2 diabetes), though the FDA left a sliver of hope for both companies (particularly Vivus).
Please click the link for the full article:
http://stocks.investopedia.
FDA - Don't Call Us, We'll Call You
Several companies have seen their fortunes take a bad turn either in the clinic or from the Food and Drug Administration.
Roche (Nasdaq:RHHBY) has essentially been sent back to the drawing board on its weekly GLP-1 drug taspoglutide, and there is a good chance that the side-effect problems that halted a Phase 3 study will prove insurmountable. Another would-be long-acting GLP-1 drug (to be marketed by Eli Lilly (NYSE:LLY) was surprisingly rejected due to FDA worries about safety and a demand for a new study.
Biodel (Nasdaq:BIOD) recently saw its application for a new formulation of insulin rejected due to sample handling and patient drop-out problems, and the FDA's unwillingness to brook a post-hoc analysis of the data. Both Vivus (Nasdaq:VVUS) and Arena Pharmaceuticals (Nasdaq:ARNA) saw their obesity drugs rejected (obesity is a leading cause of Type 2 diabetes), though the FDA left a sliver of hope for both companies (particularly Vivus).
Please click the link for the full article:
http://stocks.investopedia.
Monday, November 1, 2010
Biodel - Unsurprising Bad News
Given how finicky the FDA has become, it cannot really be said to be a surprise that the agency bounced Biodel's (Nasdaq: BIOD) application for approval of Linjeta in Type 1 and Type 2 diabetes.
What has to pour some salt in the wound, though, is that the two trials were both laid low by events largely out of the company's control. Heat damaged blood samples from India in a Type 1 study and unexpected drop-out rates reduced the statistical power of the Type 2 study to below the point of non-inferiority. Although both drugs held up fine on post-hoc studies, that did not cut it with the FDA.
So, what now?
The FDA is demanding new Phase 3 studies for both indications, and I would estimate that is a $160M bill for a company with less than $25 million in cash. Theoretically, maybe the company could raise enough for one trial with a share offering, but that would be horribly dilutive right now. There's also a reasonable chance that the company could find a partner (Linjeta *works*!), but the terms would not be even slightly favorable to the company. In fact, I imagine the conversation would go something like, "there is the barrel ... assume the position". Making matters worse, it is not practical for the company to partner just the Type 1 (or Type 2) indication - once one version gets approval, there will be rampant off-label usage and no really accurate way to track it.
I hope the company can figure something out. My hunch is that they will partner (or sell the company) and investors will get a partial recovery on their investment, but nothing like what they could or should have expected a couple of years ago.
What has to pour some salt in the wound, though, is that the two trials were both laid low by events largely out of the company's control. Heat damaged blood samples from India in a Type 1 study and unexpected drop-out rates reduced the statistical power of the Type 2 study to below the point of non-inferiority. Although both drugs held up fine on post-hoc studies, that did not cut it with the FDA.
So, what now?
The FDA is demanding new Phase 3 studies for both indications, and I would estimate that is a $160M bill for a company with less than $25 million in cash. Theoretically, maybe the company could raise enough for one trial with a share offering, but that would be horribly dilutive right now. There's also a reasonable chance that the company could find a partner (Linjeta *works*!), but the terms would not be even slightly favorable to the company. In fact, I imagine the conversation would go something like, "there is the barrel ... assume the position". Making matters worse, it is not practical for the company to partner just the Type 1 (or Type 2) indication - once one version gets approval, there will be rampant off-label usage and no really accurate way to track it.
I hope the company can figure something out. My hunch is that they will partner (or sell the company) and investors will get a partial recovery on their investment, but nothing like what they could or should have expected a couple of years ago.
Thursday, October 21, 2010
Trick or Treat for Biodel?
Biotech CEOs should be forgiven if they feel like the FDA has turned almost every day into Halloween. Companies ranging from Jazz Pharmaceuticals (Nasdaq:JAZZ) to Alexza Pharmaceuticals (Nasdaq:ALXA) to the obesity triumvirate of Vivus (Nasdaq:VVUS), Arena (Nasdaq:ARNA), and Orexigen (Nasdaq:OREX) have all seen the scarier side of the FDA drug approval process lately. The FDA has handed out rejections to the first two, panels have recommended against the next two, and Orexigen has been batted around by investors who wonder if the FDA (or its panel) will take out their knees next.
All in all, it is easy to understand why shareholders of biotech Biodel (Nasdaq:BIOD) would be nervous these days. Although the company's Linjeta insulin could be a blockbuster for the company, problems with a pivotal study and an October 30 FDA PDUFA date have investors wondering if they are going to be left waiting in vain for the Great Pumpkin on Halloween.
Please click the link for the full text:
http://stocks.investopedia.com/stock-analysis/2010/Trick-Or-Treat-For-Biodel-BIOD-HALO-SNY-LLY-NVO1021.aspx
All in all, it is easy to understand why shareholders of biotech Biodel (Nasdaq:BIOD) would be nervous these days. Although the company's Linjeta insulin could be a blockbuster for the company, problems with a pivotal study and an October 30 FDA PDUFA date have investors wondering if they are going to be left waiting in vain for the Great Pumpkin on Halloween.
Please click the link for the full text:
http://stocks.investopedia.com/stock-analysis/2010/Trick-Or-Treat-For-Biodel-BIOD-HALO-SNY-LLY-NVO1021.aspx
Tuesday, October 19, 2010
I Think I Give Up On The FDA
With tonight's news of Amylin (Nasdaq: AMLN) getting yet another complete response letter (CRL) from the FDA on Bydureon, I am just about ready to give up on the FDA. Even though Bydureon has shown no particular cardiovascular risk, the FDA has decided to ask for a QT study - a request that is going to take at least a year to fulfill (to say nothing of another six months or so for review).
I would love to know why the FDA did not request this back in the first CRL. I cannot stand conspiracy theorizing, but I am beginning to wonder if the FDA has just decided to abandon its supposed mission of evaluating the safety and efficacy of new drugs in favor of just ruling that any and all new drugs are potentially unsafe and therefore unapprovable.
Although I think Amylin has the capital to endure this delay, and I still believe Bydureon is the best drug in its class, I do not know how anybody can just assume that the drug will get approval. It seems clear to me that the FDA does NOT want to approve this drug and will come up with whatever obstacles are necessary to block it.
By the same token, then, this is bad news for any company looking to get a new compound through the FDA. Maybe Big Pharma can still push some compounds through, but it feels like the little companies do not stand a chance.Good luck, then, to Biodel (Nasdaq: BIOD) and its problematic Phase 3 data on Linjeta - if the FDA will not approve Bydureon, I cannot see how Biodel gets through.
I wonder how long this will go on before somebody decides it is time to audit and investigate the FDA and re-examine its mandate. I appreciate and respect the necessity of protecting the public from unsafe drugs, but allowing unmet medical needs to remain unmet simply because of fanciful fears of possible harm does nobody any good. At this point, I argue that the FDA is abusing its mandate and needs a Congressional slap upside the head to remind it of its obligations to facilitate the introduction of new drugs and devices.
Anyways, I do not wish to turn this into a long-winded rant about the FDA, so I will bring this to a close. This is a major disappointment to Amylin shareholders, but it is not the end of the story yet. I still have some hope that this story will work out, but it is definitely going to take longer than I had hoped.
Disclosure - I own shares of Amylin
I would love to know why the FDA did not request this back in the first CRL. I cannot stand conspiracy theorizing, but I am beginning to wonder if the FDA has just decided to abandon its supposed mission of evaluating the safety and efficacy of new drugs in favor of just ruling that any and all new drugs are potentially unsafe and therefore unapprovable.
Although I think Amylin has the capital to endure this delay, and I still believe Bydureon is the best drug in its class, I do not know how anybody can just assume that the drug will get approval. It seems clear to me that the FDA does NOT want to approve this drug and will come up with whatever obstacles are necessary to block it.
By the same token, then, this is bad news for any company looking to get a new compound through the FDA. Maybe Big Pharma can still push some compounds through, but it feels like the little companies do not stand a chance.Good luck, then, to Biodel (Nasdaq: BIOD) and its problematic Phase 3 data on Linjeta - if the FDA will not approve Bydureon, I cannot see how Biodel gets through.
I wonder how long this will go on before somebody decides it is time to audit and investigate the FDA and re-examine its mandate. I appreciate and respect the necessity of protecting the public from unsafe drugs, but allowing unmet medical needs to remain unmet simply because of fanciful fears of possible harm does nobody any good. At this point, I argue that the FDA is abusing its mandate and needs a Congressional slap upside the head to remind it of its obligations to facilitate the introduction of new drugs and devices.
Anyways, I do not wish to turn this into a long-winded rant about the FDA, so I will bring this to a close. This is a major disappointment to Amylin shareholders, but it is not the end of the story yet. I still have some hope that this story will work out, but it is definitely going to take longer than I had hoped.
Disclosure - I own shares of Amylin
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