The FDA was not created to fulfill the role of parent or God, but by and large it is nevertheless a good idea to do as the agency suggests. That makes the decision of small oncology biotech Exelixis (EXEL) to proceed with a clinical trial design that the FDA does not agree with a curious one. While Exelixis may indeed succeed in this approach and bring cabozantinib to the market fairly quickly, it is a risky strategy that bring a lot of volatility to these shares.
No SPA
Clinical trial design and FDA policies are admittedly confusing to the uninitiated, so here is the simple version of what is going on with Exelixis. The company had hoped to get the FDA to sign off on a Special Protocol Assessment (SPA) for its Phase 3 study of cabozantinib in very sick advanced prostate cancer patients, but the FDA has elected not to do so.
Read the full article at Seeking Alpha:
Exelixis' Curious And Risky Strategy
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