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

To: Bluegreen who wrote (14623)	9/16/2000 7:55:05 PM
From: aknahow	Read Replies (2) \| Respond to of 17367

Bluegreen, shuss! Enough already. Leave Manfred alone. I am learning about the scientific method and anarchy. Difficult to understand how someone that respects the scientific method and our regulator, the FDA, has no idea of what Subpart E is. Cacaito has gone looking for the Glasgow scores involved in the test, but Manfred has already accepted that the trial was based on the subjects that were least sick. Yet many died before the treatment schedule was completed.

To: Bluegreen who wrote (14623)	9/16/2000 7:58:19 PM
From: Robert K.	Respond to of 17367

For your information Manfred, subpart e is designed to give the fda great flexability to speed and approve new medications to market where life or death may be a issue, and where no real alternate is available. Bpi was granted subpart e status by the FDA, but apparently the fda so far has allowed little in the way of getting this beneficial drug to market. If this was a cancer drug, or a HIV drug, this would probably be a different story.

To: Bluegreen who wrote (14623)	9/16/2000 8:37:18 PM
From: Cacaito	Read Replies (2) \| Respond to of 17367

Subpart E does not mean subscientific, or substandars. The logic of subpart E is that a "surrogate benefit" that is known to be a factor in the final expected outcome could be the basis for approval of a drug. simple example: If drug A is able to disolve clots and disolving clots is clearly good to save a limb, then one could MAYBE considered just disolving the clots as a basis for approval... of drug A... ... Catch 22 is that surrogate factor MUST BE PROVEN epidemiologically and that is rare on itself and difficult on itself , in the case of xoma neuprex for meningo NO SURROGATE FACTOR is identified clearly as a PROVEN PREDICTOR of less mortality or less morbidity. The one and only statistically significant point in the study was POPC at day 60 (p = 0.019) and this is NOT a proven predictor of anything, more if one gets the data for day 30, or 45 or 75 what is the p =? to? why not showed that data, were it probably is or not as striking as the shown one. Even if all of those days are, still is not a proven predictor of anything yet, the POPC came from where? where was it validated? where is the clear predictor: NO WHERE! So, Mr Blue and Green, Subpart E is not your dream dump it there in the recycle bin and we will get a sure by product, is an stringent albeit flexible tool for real proven facts, not Si board imagination concoctions.