So is this where the "fun" crowd camps?
Greetings from Katie...
couple of posters on Yahoo have stated that additional phase-2 trials will be needed before commencing phase 3, but they have not substantiated such an opinion, IMO.
My thoughts are GENR should conduct one more Phase II with a larger patient population (65) to do just as Dew suggests, to fine tune the dosing, spearhead labelling and perhaps even throw in a comparator, maybe even test it for another indication besides 'wet' AMD. They can still enroll a Phase III at the same time. The FDA has a mind of it's own, irregardless of the new head, I think it's best to deal with these folks with all your bases covered. Pharma sometimes gets ahead of themselves when their investigational yields compelling data in these Phase I/II study's and then 'issues' come up in Phase III which should have been addressed in Phase II. To me there is some risk involved in not having a Phase II conducted with a comparator. I'd prefer GENR be on the safe side, and fine tune it now. I call it CYA.
One might also consider that conducting an additional Phase II, with a III pivotal enrolling may get Squalamine to market in a more expedient manner, leaving a second pivotal open to another indication.
All of the above depends on Dr. Levitt's ability to negotiate the protocol and present the data to the FDA. I would make the FDA spell out their needs and requirements on paper i.e. the protocol, especially if GENR opts to forego another Phase II, and proceed directly to pivotals.
It JEST depends on the FDA folks, I do like the fact Dr. Levitt has managed to align Squalamine's results with the advocates. Having the advocates on your side ALWAYS helps!
katie...
