Company presentation updated
Goes into deeper details on the Soraya data.
I've been investing in biotechs for a long time. If the FDA doesn't accept the BLA I'm getting out of small biotechs in general as I fundamentally wouldn't understand what the FDA criteria is anymore in trial design.
That's not to say the company couldn't get a CRL on the submittal but it they do it's going to be for contract manufacturing control reasons which are solvable in a reasonable timeframe.