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: I. Luttichuys who wrote (958)	6/5/1997 9:50:00 PM
From: Brad C. Dunlap	of 1762

Hi Bennett, I certainly can't speak for the FDA but will assure you that smithkline/idec were very encouraged with the data. The street had a hard time with the rashes that developed at the higher doses that later were associated with the administration of the drug. The negatives that were highlighted from the phase II were not the transient depletion of t-cells but rather the few rashes in the high dose groups. Now that I'm reviewing the data from each study here is the terminology of printed matierial from last years ACR conference. Phase I 25 patients, no toxicity,no depletion of T-cells. Phase I, 40 patients, no depletion of t-cells. The larger phase II study results included these prior results and the wording was as I posted earlier. I doubt that Smithkline would be using "no toxicity language" if the FDA viewed this as a potential problem. Also the best answer to your question is the fact that Smithkline has moved into two expensive phase III studies and if they thought the data was questionable, I believe this drug would have been dropped like a hot potato. Once again I like what I know but sometimes it's what you don't know that hurts.

Report TOU Violation

Share This Post

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next