Tuesday, April 05, 2022 3:09:42 AM
This is never easy to predict. As midas says frequently companies raise most often when they can, not just when they need to.
This said however, they presently have mentioned that they have enough of a cash runway until Q3 2023.
Given EMA submission in Feb, and a approx 12 month timeline for EMA review, then we can assume Feb or March 2023 EMA approval.
For the FDA we can assume resubmission of the BLA by September 2022, with a 6-month review process as this is a BLA resubmission. This might put FDA approval at about Feb or March 2023 as well. Of course assuming all check with fill and finish etc formalities go smoothly.
Now both of these approvals look to me as if they will come in Q1 2023.
Therefore I see no specific reason for PLX to dilute pre either approval as the data is fantastic and I can't see any reason so far why the EMA or the FDA would not approve the product. Thus if you were going to raise it would make most sense after an approval.
If this were the case however one might not see a raise at all. If the approval(s) do come in Q1 2023, then both of those events trigger their own respective milestone payment from Chiesi, which I would feel would shore up the PLX coffers decently, and following from that from approval the sales would begin and revenues would come in which together might negate the need for raising.
Just my 2 cents on a difficult to predict question.
Best,
Spidey
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