The science is in question.
A 30,000 page IND that took months and months to get through with caveats by the FDA.
2 years of PAR doing non-clinical studies in the background and a failed dosing study results in very very lukewarm reception by the FDA.
TGA provisional approval gate should have been by now - so why the radio silence. The timeframe should be 30 days from submission at this checkpoint - a submission they delayed for four years.
and if you think that’s bad - a fund management firm that has no experience in pharma is now hired as their business development consultant to get them out of this mess.
Where we at?, page-666
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