I think it was you who recently posted that someone would be crazy not to have a pre-IND meeting with the FDA. That is true, but only with the added context, that is usually assumed: one should request the meeting to be held at the most strategically advantageous time during the completion of the IND package.
The FDA will grant a Pre-IND meeting at any time. You only get one such meeting, so legitimate drug developers choose the timing pretty carefully, to get the most out of it. In this case, NNVC had their pre-IND meeting without having completed any of the GPL-required tox studies, which is the least useful of all possible times to have this meeting.
They hadn't even PR'd the selection of a lead candidate prior to this one about the pre-IND meeting, which makes their comments about their "lead candidate" somewhat unbelievable.
Obviously, that meeting was for show to pump the stock, rather than for actually developing a lead. (assuming that actually did have that meeting).
Also, the FDA doesn't hand out random advice, or give "favorable comments", during pre-IND meetings, as reported by NNVC. The applicant provides data, and ask the FDA questions, to which the FDA replies. All that NNVC could have accomplished in their meeting would have been a theoretical discussion, showing the FDA their development plan, and asking "is this okay"? To which the FDA would have answered "Yes" if it was a standard plan. Thus, perhaps, a "favorable comment", and the lack of any need to really have selected a lead candidate.
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