Biotech / Related Ideas

[ruengies3]

I asked Cobalis and got an answer. I wish I understood it.

I sent an email to Cobalis asking the following:
Why was it necessary to run twin Phase III trials of PreHistin instead of a single additional Phase III? From reviewing documents Cobalis submitted to the SEC, it appears the first Phase III was deficient in some way -- only be considered "supportive" of approval -- and couldn't qualify as being one of the two Phase IIIs required for FDA approval.

Steve Hecht replied:
Need two trials that the FDA deems pivotable. The first trial, in the Company's view, would probably have been deemed supportive.

Do you know what distinguishes one from the other and why it matters?