RE:RE:RE:Let's call a spade a spadeThis is the last info I had from a conversation with Fred a couple weeks ago if I recall. However, the inspection has to match the FDA availability and the batch in process in the Laval facility. Will there be a timeline change for the inspection? Obviously I can't answer. The FDA is really in complete reorganisation.
The guys with who PLI was dealing in the past where specialist in plasma product. The new guys (thanks to Trumpet) have a gene background. There is a complete reorganisation at the FDA since a couple of months and it is not done yet. Many seats are still not given so bad timing (once again) for PLI.
About leaked info at the FDA, humans are humans and big fund have the money to get info, but since this would be illegal, I want to believe that it does not happen on a large scale.
BLA will be accepted, I have absolutely no fear about it. just a matter of time.
Hopefully, with Bruce back in place, there will be more control on cash burn to avoid the need of a financing before the SP recover after the BLA is done.