SI
SI
discoversearch

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 : Imclone systems (IMCL) -- Ignore unavailable to you. Want to Upgrade?


To: 613 who wrote (2074)2/20/2002 4:56:20 PM
From: Cacaito  Respond to of 2515
 
Good, they are a day late and several billion$ short due to the same data that they could have provided in months now they will have in weeks? very impressive!

The drug was being evaluated on a "surrogate" goal, that is a goal that pressumely will imply something else, in this case tumor shrinkage pressumely correlates with increase survival, that was the shortcut and an appropriate one that was GRANTED by the Fda to Imcl, they botched their chance.

Notice that the 22.5%, 15%, your 10% , the solo trial 10% are about a surrogate point "tumor shrinkage" not about surviaval, they are not equal at all.

Therefore, your 10% theory apply only if survival were the case, of course it will be good to have 10% increase chance, but to prove that a pII is not enough, as the effect is lower in %, the sample size needs to be larger (and placebo controls more necessary).

Imcl problem is not just this "faulty" trial, all the other trials will be highly scrutinized, there is a big campaign agaisnt the Fda by the soap opera camp, even the WSJ put a little (idiotic placebo talk) on it, and the Fda can not go and pr around like a bunch of monkey analysts a la mccammant (is or was a shareholder). Who is to warranted that the other trials are running in expected order? the wacksals?

Bmy could have no approval in 1.5 years but they are much better that the imclowns, anyway no one could do a good Fda Bla with a faulty drug.



To: 613 who wrote (2074)2/21/2002 12:52:20 PM
From: Cacaito  Read Replies (1) | Respond to of 2515
 
Look at the Zevalin approval, tumor regression was the criteria for approval, but they have a placebo control group, side effects very significant, and not proven survival increase. This is clear sign (as in Scios drug, and Gleevec) that the FDA is very keen to approval of drugs with surrogate goals, but that the quality of the research must be substantial, QUITE REASONABLE AND FAIR to companies and patients in need!