IMNR - Immune Response 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 : IMNR - Immune Response

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next

To: Bob Walsh who wrote (1229)	12/22/1998 2:02:00 PM
From: Andrew H	Read Replies (2) of 1510

>>I believe it indicated that for people on prednisone the results were not very good but that for those not on prednisone the results were good. This is understandable and quite good<< It may be good in theory but not in practice. The FDA is going to look at the results of the trial as a whole, and will be very unlikey to make separate rulings for those taking larger doses of prednisone vs. those who were taking smaller doses or none at all. Although this may help IMNR in designing their next trial. It sounds like a poor trial design to me, which they are now trying to rectify by saying the prednisone was a confounding variable. They should have known that before starting the trial. Basically they did not show statistical significance in the trial overall, which doesn't not bode well for the drug or for the FDA review. The fact that there was statistical significance after the third injection is nice, but not terribly relevant, since the FDA will be evaluating the trial as a whole.

Report TOU Violation

Share This Post

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next