This meeting is to confirm their house is in order in terms of preparation to submit the BLA. It’s like a checklist so management is looking for confirmation that there isn’t something that is going to be required that will create an unforeseen delay. Because the safety data from the investigational P3 is tied to the Combo BLA, Mono will be part of the discussion.
The major event is Combo BLA acceptance by the FDA. That takes place after the BLA has been submitted and the FDA reviews and finally accepts the BLA. Review can take a couple of months. My understanding is Acceptance translates to drug approval.
Just as Finesand has run valuations on Combo, management has outsourced this very important needed information. It will be interesting to see how the valuations compare but more importantly how an interested suitor will value Combo. Obviously if Mono Interim suggests a realistic shot at approval valuation changes radically. The thinking is to determine during the Combo BLA process if Mono is in play or are we going it alone with Combo. IMHO a deal has not been in the making because it is not yet known just exactly what we have on the table. Interim Mono Efficacy is a huge inflection point in the end game.
I’m not an authority by any means but that is the way it has been explained to me.
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