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poorgradstudent

03/14/13 1:47 PM

#158322 RE: iwfal #158319

Gern

Disagree - the cancellation of the PV trial without explanation adds murk IMO, and when added to the paucity of data out of the ET trial (there are at least 3 important aspects of ET, two of which overlap with PV. And the ET paper was silent on the PV-overlap data (spleen size and symptoms).) I think it is a very good bet that the PV trial had some significant issues.

The real problem with that is that, if anything, MF has more in common with PV than with ET. So if PV was a bust... .



The distinction I was trying to make in the follow-up post, is that we're clear on what they will / won't do. I conceded that the reasons themselves are opaque, but for any reasonable biotech investor that lack of clarity speaks volumes.

I think they're trying to find a quick path to market, and the order of preference is MM > MF > ET/PV. Poor activity as single agent in MM means they moved away from it (which I agree with), so that leaves the current MF trial as their best lead. The costs / length and general ambiguity about getting a drug approved directly for ET / PV* is likely the reason they're on the sidelines there.

So agreed that there is opacity here, but I just don't think the situation is hard to decipher.


* I say this because I don't know what an approvable primary endpoint for ET / PV would be. This type of ambiguity plagued INCY in their MF trial until they got the SPA.
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mcbio

03/14/13 6:26 PM

#158343 RE: iwfal #158319

I don't think you can say they "cancelled" the PV trial though. I thought the reference per the CC was GERN had enough PoC in the ET/PV trial to be able to stop the trial. they stopped enrolling both additional ET/PV patients.