Biotech Values

[DewDiligence]

[Update] Can GENR proceed directly to phase 3?

[Repost of message #32383 on yahoo]:

>> can they just enter Phase III trials in the US if the Phase II was held in Mexico? <<

Yes, they can go directly to phase 3 –the question is whether they should.

At the recent Rodman & Renchaw webcast, Dr. Levitt signaled that the company is planning a phase-2 trial to test a monthly retreatment schedule, but I think this plan is malleable and it could be overruled by GENR’s partner.

My view is that proceeding directly to phase-3 with a partner is not unduly risky provided that the companies secure a Special Protocol Assessment from the FDA (see message #51 on this iHub board).

The phase-3 trial(s) could test multiple dosing schedules; although this would significantly increase trial size and expense, I think it’s to GENR’s advantage (as well as the partner’s) to trade off a higher expense for a shorter time to market.

>> If so, then it would seem like a sugar-daddy is all that is standing between us and a 10 bagger within 2 years. <<

Bingo!

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P.S. You can vote on the question of proceeding directly to phase 3 at the following link:

http://www.investorshub.com/boards/board_surveymenu.asp?board_id=1418