Biotech Values

[DewDiligence]

The Squalamine dosing schedule and expectations for the ”209” trial:

[This message is a repost of #46833 on Yahoo. Also see #msg-2922504 for discussion of the “208” trial which includes Visudyne.]

I think matching the monthly retreatment schedule of Lucentis played at least some role in GENR’s design of the phase-2 Squalamine trials, but GENR would not have opted for monthly retreatments for competitive reasons only.

A monthly retreatment schedule for Squalamine may be close to optimal for visual stabilization. A retreatment schedule even more frequent than monthly might be able to produce marginally better results than a monthly schedule, but the tradeoff of marginally better results vs the added inconvenience and expense to patients would be unfavorable.

(To be clear, I am referring to the retreatment schedule following the initial “loading doses” which will probably be done weekly as in the Mexican trial.)

Despite the above, I don’t think investors should expect a 100% rate of improved/stable vision in the “209” phase-2 trial (the main phase-2 trial with 100 patients). There will almost certainly be a few patient dropouts in a study lasting as long as 48 weeks. In an “intent to treat” calculation (which is the kind of calculation normally used by the FDA), dropouts are counted as non-responders.

Moreover, in the larger sample size and longer duration of the “209” trial, as compared to the Mexican trial, there might be a few patients whose response does not last or who don’t respond at all.

It would be great to achieve a 100% rate of improved/stable vision in the “209” trial, but I think a rate in the high 80s or low 90s is more realistic.

Comments?