FDA met with the company for two post PII meeting, then declined the third requested meeting some time ago,, told PVCT they had all the information they needed.
The SPA process we were talking about today was addressing the process after the first 45 day review response, right? "While the review process could occur in as little as 45 days from the date of submission, we expect it will be an iterative process, and thus, more time may be required to work with the FDA on a study design agreement."
That is the repetitive processes yet to come, Dees was clear about that. It appears PVCT wanted something out of the third meeting but did not get the chance...now they have to write, but are also preparing investors for the real possibility that they will miss the mark with a SPA
Who is trying to cloud the issue here Howard? |
