Silicon Investor (SI) -- The First Internet Community

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 : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?

To: Cacaito who wrote (10603)	7/2/1999 12:41:00 AM
From: aknahow	Respond to of 17367

Thanks for the complete reply. BTW article on the SOC in the U.K for stroke. Interesting. news.bbc.co.uk

To: Cacaito who wrote (10603)	7/5/1999 10:57:00 AM
From: aknahow	Respond to of 17367

Probably mentioned before but any company with experience in running clinical trials on AIDS patients might also have an interest in Mycoprex. But my real motive is to explore further the implications allowing XOMA to look at the blinded data sooner rather than later. What produces such a change? We were all told that looking at the data earlier would introduce a bias among those who would run the evaluation. Now it becomes apparent that it is more important to analyze the data then worry about the bias. Is this because of the nature of the disease, with the major endpoint being death, which probably does not even change much after the ten day end point. How does such a change come about? Does XOMA beg? Does the DSMB ask the FDA? Does the FDA proactively ask the DSMB to see the unblinded data? Why ask these questions? The answers would provide insight into the significance of the ability to analyze the data early. Small things at times are important. Clearly this "even" was initiated by one of the players. If it was XOMA whatever they said to the FDA was convincing and more than just how about letting us see the data early. Also, XOMA does not just decide, "Gee, sure would be nice to see the data early, lets use up our good will at the FDA and ask for an early peek, just for the heck of it." Something motivated them to risk asking for it and feel confident they had the reasoning to back up such a request, if indeed they were the initiator. Is opalpril actually right in that the DSMB might have been the initiator? It had been my understanding that the DSMB does not unblind the data even for the FDA. It makes available its' reports on safety to both sides. Will Mr. Market, even care? Don't know. I care. Its' a bigger story than one would think. No reason for this to just happen without a reason. When everything over and done with I think it is worth finding out what really happened as it would enhance our understanding of the drug approval process. While I don't regret that some of the biotech brains on other boards don't own XOMA I regret that they don't follow some of the issues. I think they would have valuable input into how an early peek at the data gets permitted and the implications.