Replies to post #149470 on Biotech Values

[bladerunner1717]

jq,

The FDA has told ECYT that they will accept a single study in PROC using PFS as a primary endpoint and they have put that in writing. There is no credibility problem here.


Bladerunner

[mcbio]

No, they had succeeded in both PSOC and PROC in ph3, PSOC last year, PROC this year. Avastin is approved for 1st line OC already, recently recommended for PSOC from CHMP. I had this discussion with you before that ECYT's claim they can get approved in US with PFS alone is not credible. Otherwise Avastin would have filed in US already.

I note blade's comments regarding potential approval in the U.S. (#msg-79975186 ) and would just question if you are entirely dismissing the EU opportunity just because Avastin may be further along with PROC patients. Obviously we will ultimately need to compare efficacy and safety of both Avastin and vintafolide in PROC patients. And at ECYT's current market cap, financial strength, and deep pipeline, I'm not sure it would make sense to dismiss the EU opportunity with their lead drug (again, lead drug on top of a deep pipeline). At this valuation, I intend to hold my shares for awhile.