Replies to post #162 on Biotech Values

[drbio45]

can squalamine go directly into phase 3

Here is an example of a company that did an open label(no placebo) trial, in another country(Israel)and is going into a phase 3.

http://www.corporate-ir.net/ireye/ir_site.zhtml?ticker=ptie&script=410&layout=-6&item_id...

So, I think there would be a way to get it done. I think the only thing holding it back would be not knowing what the proper maintenance dosing should be. Every 4 weeks, 8weeks, 12 weeks. You want to get the best result because nothing is a slam dunk.

[mskatiescarletohara]

Dew and Rstor....

Running additional phase-2 trials in parallel with the phase-3 studies is clearly preferable from a time-to-market standpoint, and this may be an issue GENR’s partner deems to be of considerable importance.[/i/]

Remember this, many drugs are approved on an accelerated approval basis usually backed with Phase II studies, and a pivotal underway or near completion. TRMS's Fuzeon, and ABT's Kaletra for example...DNA's Avastin too....

GENR and the potential partner have a much greater chance in getting the compound to market by launching a Phase II study to specifically address the dosing, labelling, scheduling and such.

If the FDA wants this drug on the market, and is impressed with the data, they will set the path for GENR to walk to get it there. Apparently, they want to see another Phase II study conducted, so they can finalize a pivotal protocol.

katie...