Replies to post #48593 on Biotech Values

[ghmm]

evidently there was something in Encysive's data as far as safety that the FDA didn't like.

Who said anything about safety? The PR implies did not show efficacy on another board the discussion centers around probably a center or two (the one with Dr. Lawrence at least) had some/all of the data excluded and likely caused the P value to fall beyond what would have met statistical significance. This makes the most sense of anything and seems to be supported by the little wording in Encysive's PR.

The liver monitoring is being required by Gilead and likely would have been also for Thelin. Claims that Ambrisentan has a lower incidence of liver tox seemed to fall on deaf ears as they still got the black-box label. So Endothelin Receptor Antagonist safety is a class effect, at least as far as the FDA is concerned but the benefits to patients exceed the small risk so approval with liver monitoring beets no drug at all.

[rkrw]

ENCY.

They did disclose:

"THELIN did not demonstrate the evidence of effectiveness needed for approval."

Now I understand why he wouldn't disclose for competitive reasons :-)

[Bio_pete]

Ency - I really didn't follow the company that closely, but I bought a few shares friday since the risk/reward ratio was favorable. ENCY has a proven track record with Argatroban's FDA approval not to mention three positive regulatory opinions for Thelin in hand. In addition some analysts think the company is undervalued even without the US market. I have no idea how this decision will impact EU sales so the CC spin should be interesting. Win some lose some.