Replies to post #469 on Biotech Values

[DewDiligence]

Re: SPA in action:

>> Is it your opinion that GENR in concert with the FDA will submit an SPA for Squalamine for the AMD indication? <<

To embark on phase-3 trials without the feedback from an SPA strikes me as reckless, so it is my hope and expectation that GENR and its partner will indeed submit an SPA.

>>Does an SPA request only come from the FDA or can GENR request consideration. <<

GENR and its partner would request an SPA in the form of a detailed written submission. Following the FDA’s review of the written submission, the FDA, GENR, and GENR’s partner would hold conference calls or in-person meetings to resolve any outstanding design issues. In many ways, the SPA is similar to the drug-approval process --with the obvious distinction that the outcome of the pivotal trials is not yet known during the SPA.