Biotech Values

[DewDiligence]

IMCL – ABGX post-mortem:

[Here are a couple of posts from the Yahoo IMCL board, which not surprisingly turned into a zoo today.]

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Advice to IMCL longs:
by: DewDiligence
11/03/05 04:00 pm
Msg: 329921 of 329971

Stop trying to pretend that the Pani results are weak or not good enough for FDA approval. That won’t get you anywhere.

Instead, start thinking about how today’s news affects IMCL’s franchise. For instance, will Pani be used off-label in the third line in combination with chemo? I think it will be, but only a little because it may not readily be reimbursed without any clinical data in this regimen. I could be totally wrong, but these are the questions one ought to be asking, rather than complaining to the referee that AMGN is not playing fair.

I think I’m as familiar with biotech scams as anyone here and I see no scam whatsoever in play. Accept the results and incorporate them into your valuation model. I think IMCL still has great value—but not quite as great as it had yesterday. JMHO, FWIW
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Here’s a reply to a disbeliever, later in the same thread:

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Re: Advice to IMCL longs:
by: DewDiligence
11/03/05 04:48 pm
Msg: 329964 of 329971

The *median* PFS value is immaterial—the metrics that matter for hitting the primary PFS endpoint are the hazard ratio (HR)—an extraordinarily good 0.54—and the p-value, which was also outstanding. The HR measures the magnitude of the clinical benefit and the p-value measures the statistical significance of the result.

>How many analysts and how many of those who follow the development of erbi and pani have thought abgx/amgn would use tumor progression RATE as an endpoint in the trial?<

“Tumor progression rate” is a synonym for PFS, which is a widely-used primary endpoint in these kinds of trials.

PFS is defined as the minimum of the time to progression (TTP) and the time to death. From a practical standpoint, PFS and TTP are nearly identical, but the FDA prefers PFS because it can capture the effect of death from unexpected toxicity.

[Posted as a reply to: Msg 329951 by semibittersweet]
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