Given the beating FDA has taken in the Vioxx hearings, it would not surprise me to get an "approvable" this week instead of "approved", with the condition being full analysis of the two-year safety and endpoints.
These are government bureaucrats accused of "too fast to approve" and "too slow to monitor safety". Cover thy ass is the first commandment of working for the government. Just imagine the outrage if Antegren proves to be unsafe 5 years from now....FDA asked for early submission on one year data of a two year trial. The second year is now complete. Wouldn't it be safer for FDA to wait for two-year results before the final OK?
Yeah, yeah, the one-year results are compelling......that's what caused the request for early submission. But now, the fire is hot over FDA not "protecting the public". The safe way for the bureaucrat's ass is to issue "approvable" pending analysis of the two year results.
I don't foresee an FDA "knee-jerk" reaction to the Vioxx or senate hearing circumstances. If you believe the FDA errs on the side of aproval, you haven't been around this game very long. The FDA asked for early submission to get this product to market as quickly as possible. It will be approved, and the companies notified by Nov. 23. Official release may come that day or the next. Bank on it.
A week or two ago someone here posted this link, which contains a very complete fall-2003 writeup of how the FDA operates, with particular regard to PDUFA daters, and responses to NDA's and BLA's (I believe Antegren is covered under the BLA rules, being a "biologic").
Here's the web site: http://www.trends-in-medicine.com/Aug2003/FDATimelines083p.pdf
Unfortunately, it seems to be "copy-proof", so I can't reproduce any portions of it.
At any rate, the way I read this article is that they don't issue "approvable and non-approvable letters" for BLA'a which are not approved.
Rather, they issue "Complete Response letters" in these cases, which list all the deficiencies which must be remedied in order for the drug to be approved. There are a lot of interesting details in the article, including the different types of responses to "Complete Response" letters, etc.
Assuming that this 2003 article is operative, it suggests that all the financial analysts and YMB posters who continue to talk about "Approvable Letters" are a bit out of date, to say the least.
Am I missing something here?
Perhaps one of our resident FDA gurus can take a shot at explaning these distinctions to a creature with a VERY small brain indeed. TIA.
Think again. The drug will be APPROVED.
The guy testifying before the senate committee last week was just some nutcase. He's been saying the same thing for years. And it would seem as though you know nothing about how administrative agencies work. They cannot, for even one second, act as if they've done anything wrong. It will be business as usual. And if you think about it, the whole Vioxx mess was hardly the FDA's fault. I'd lay the blame right at Merck's door. From what I've read they've known of the dangers of the drug for years. Surely they had the duty to come forward sooner rather than later. You can't blame their behavior on the FDA. Look for an approval in the morning.
There are over 300 patients who have been on Antegren for over 3 1/2 years now. P-II trial patients were promised continued supply. Also, the Crohn's maint. P-IIIb is all comprised of responders from last years P-III, also in their 3rd year.
SO....we have OVER 600 PEOPLE who have taken Antegren for 3 years!!!!
Cox-2's may be unsafe, but ANTEGREN IS, AND FDA KNOWS IT!
Now be sure to short some more in the morning.
dont think so, this drug is eagerly awaited by many ms sufferers, it will make a significant difference to them, the fda will take a lot of heat if they dont approve now esp after speeding up the process themselves
< Yeah, yeah, the one-year results are compelling......that's what caused the request for early submission. But now, the fire is hot over FDA not "protecting the public". The safe way for the bureaucrat's ass is to issue "approvable" pending analysis of the two year results. >
I imagine that somewhere within the issues for consideration is the topic of PATIENT.
It wouls seem clear to me that the well-being of hundreds of thousands of (mostly suffering) patients should take precedence over the ass of a bureaucrat!
Verdict: Approved without condition!
Giving an unpected 'approvable' rather than 'approved' would almost be like an admission of a problem. I hope their psychology is such that they don't want to be perceived as running scared.