Ann: FDA Accepts BLA for RYONCIL and Agrees to Priority Review, page-128

My tea leaves tell me the FDA will pass the BLA first coz they have a tiny inkling it might be useful, just in case, not that they would skimp on investigation but because it might be COVID-19 related down the track, it might attract extra resources to get it done.

Having a BLA for Ryoncil in place would mean at least initial batch to batch and manufacturing standards etc for rem-L would already be answered, something to adhere to as part of any capacity build out that will have to happen.

That would mean waiting for the trial complete if overwhelming efficacy is not reached is not too much of a problem. If rem-L is overwhelming, the BLA would be well on the way, with all the details in place and resolved, or resolved very soon, to make the way smoother for an Emergency Use Authorisation, just thought I'd add that last bit

Yeah, these would be really nice problems to have.