IDPH--Positive preliminary results for pivotal trial of ID 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 : IDPH--Positive preliminary results for pivotal trial of ID

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next

To: Roger Cranwill who wrote (430)	3/7/1997 12:20:00 AM
From: I. Luttichuys	of 1762

I tend to agree with you. FDA has already approved other therapies for CA with graver side effects probably because they consider the seriousness of the target disease entity to be mitigating. Would not the mild side-effects seen with C2B8 be all the more reason to approve for the same reason? I think not approving because of any concerns with the minor side effects would be the height of inconsistency. IDEC has applied for approval such that patients eligable will have already been treated with these more toxic therapies. If they were put through the first, what reasoning based on toxicity levels is to lead the FDA to believe that the benign toxicity profile seen in C2B8 is too much? Politics re: pressure to approve at an accelerated pace for CA drugs? Of course they would not approve on politics alone but, all other considerations being satisfactorily met, as I believe they are, what better coup for the FDA than to approve a radically new approach to CA treatment on an accelerated basis? I think they WANT to approve if they at all can do it. IDEC seems to me to have been very careful in their preparations. BENNETT

Report TOU Violation

Share This Post

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next