Biotech Values

[biomaven0]

The notion that EXEL could get a better outcome from the FDA than what they actually got may have been a canard designed to impress the investment community with how wonderful and unique the company’s drug purportedly is.

There was no mileage for them to be talking about an SPA up until a few days ago and then suddenly coming up with this plan. Just costs them credibility and buys them nothing in the long run. They set out their history of interactions with the FDA and it does sound like the FDA changed their mind (or EXEL got a very wrong read indeed).

They aren't the first company to have trouble with the FDA and an SPA - ZIOP tried hard to get one for Palifosfamide, and when they couldn't agree the shares lost something like 20%. And the ZIOP guys aren't dummies when it comes to designing clinical trials - I think they are actually about the most impressive small company oncology outfit I've encountered.

Big pharma typically don't even bother with SPA's - it's not like the FDA can't tear them up after the fact if they don't like what they see. They certainly are helpful to the investor to the extent you don't trust the company to be truthful about their interactions with the FDA, but arguably sometimes the hurdles in a SPA will sometimes be higher than if the company had just gone ahead with their own trial design.

Peter