This ann doesn’t really tell us what we wanted IMO. It is very vague in terms of the actual guidance given by the FDA or any other details surrounding the meeting, the only thing said is that it was “clear guidance”, and that there is a “clear pathway” but no further elaboration.
The FDA has requested further data which will be used to “start human clinical trials”, the data will be “ready for submission in the next several quarters”, seems to imply that this will be a while away from now. I think it is likely that Recce did not receive the outcome they were looking for during their talks, and will be going through the full phase one human trials rather than skipping through them (e.g. via accelerated approval) as some users suggested may be the case.
The final two paragraphs to me also imply a concern around funding, “the company will continue to manage its finances prudently”, I don’t see why this statement would be included in this ann unless aluding to a need for CR soon?
Thoughts?
RCE Price at posting:
21.0¢ Sentiment: Buy Disclosure: Held
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