Right now, I have very little concerns about FDA approval. The remaining question is after all, in relation to a a tissue finding in one organ in single study on rats without any side effects and with no reported findings in people or tests on other species. At worst, PAR will just be asked to ensure they monitor and look out for it in their trials.
The only issue of concern is this: "We currently have 71 mil cash, this is sufficient capital to commence p3 and 008 and mps studies and pipeline studies (ARDS, CHF). Once we have finalised the process with FDA, the company will have a clearer view and will update the market as reqd."
i.e. They seem to be unsure themselves if they have enough cash, so yet another capital raising may be required. It probably won't be too much, but the need to repeatedly go back to the market for cash is just not a good look and weights on the stock.
If this is the case, I don't think its great capital management to be honest, not by a long shot. They should have raised more than enough capital with a buffer for minor delays or cost increases.
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