Biotech vs. Shorts Message Board

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Biotech vs. Shorts

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next

To: Vector1 who wrote (206)	8/31/1999 4:23:00 PM
From: Gordon James	of 427

V1 wrote: My theory, and it is only that, is that the FDA staff which hates the 6 month review regulation turned this into a 9 month review by rejecting the application on ministerial changes that could have been handled a few weeks ago with a phone call. I know the company feels blindsided and I do not blame them. An echo of your thoughts, from the Bioworld piece: Dietz said he is "baffled" by the actions. "I came to the quick conclusion that the FDA was trying to buy a little time," he said. "I think they have so many priority review applications that they just needed a little extra time. The basis of the FDA's comments seem so trivial that one would have expected them to be addressed during the review sessions rather than up front before accepting the BLA. It seems more like a delaying tactic than the FDA having actual issues with the filing." PB, thanks for the link... Gordon

Report TOU Violation

Share This Post

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next