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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: Biomaven who wrote (10329)2/7/2004 3:17:07 PM
From: Biomaven  Respond to of 52153
 
And one more I missed posting the first time:

Peter,
Here is my take (qualified by the fact that my reading of trial results has never been informed by a tutorial by a knowledgeable investor and probably poor understanding of some of the plain language (with implied state of art context):

I rate the PR at 4 out of 10, based primarily on the ABSENCE of qualifying and supplemental information that would make the data GIVEN in the PR more readily assessable:

1. Tumor response as primary end-point is not qualified at all by quantitative minimum criteria (this may be standard fare).

2. No p values at all are attached to the primary end-point of the trial. The protocol established this as the primary end-point, yet no analysis, p-values or otherwise are discussed to compare relative success or failure, vs. secondary end-points.

Is this an ITMN-like situation with IPF?

3. "Best overall tumor response rate" is not qualified or explained vs. "confirmed tumor response rate". If not confirmed, what does "best" response rate measure?

4. "The one year survival for patients treated with the combination was approximately 19% (ITT).
Median survival for patients treated with the combination was 8.9 months (ITT)." What, absent a placebo or other comparison, does this tell us? All we know is that ITT population had a minimum 3-month survival expectation.

5. The anti-G17 response population is interesting, but certainly not dispositive of anything.

Respectfully submitted,

Steve

(quidditch)