The way Phaedrus sees it (and I don’t know whether it is...

The way Phaedrus sees it (and I don’t know whether it is accurate) under the thread about the FDA endorsing the HF-LVAD pathway is: “… the go/no go time will be within a month or so after the Minutes of the upcoming Type C (the pre-BLA) are released - because at that point all undertakings to the FDA will need to be underwritten or funded so that work on assembling the BLA can commence (and there's no room in the budget for anything like a 3rd trial (PhIII/IV) and won't be IMO until breakeven).”

Note that the Type C meeting has been or will be requested, and we don’t know if it has been scheduled.

If the above guesswork re timing (for the company to nail down the regulatory pathway) turns out to be what happens, we can only wait. The SR-aGVHD meeting with the FDA will be in the next few days. That, rather than what we speculate here, is going to determine if there are follow-on actions in other indications, especially heart.

Any thoughts from the wise people here?