Lots of noise and much confusion but the message I got was that...

Lots of noise and much confusion but the message I got was that an adult trial was needed to confirm data.

I believed SI mentioned it was to be a targeted trial that would recruit the worst-case lowest survival rate participants that had not achieved results from previous treatment not a randomized & placebo trial which makes sense but was this what the FDA wants well who the heck knows.

Question will be how many, how long and what will be considered baseline for success and this I believe can only be determined with consult with FDA or they could shit can the whole thing once again.

SI also mentioned facilitating as an academic trial but regardless of, if we have to put something else on the bench to get this done then so it must be as this appears to be pivotal to company as market has shown.

Would be good to be looking at earlier data for this kinda remember it being somewhere out there and do we not have a more robust better-quality product now?

Anyway, until then I guess it's sit ,wait and hope that the FDA at least comes to their senses and allows usage for children at least and they are not setting us up to fail to protect BP.

Cheers & GLTAH