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.
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”