@Phaedrus that was not me, my questions were after the meeting...

@Phaedrus that was not me, my questions were after the meeting in an informal setting ...

but now that we are revisiting this conversation about EAP for kids under compassionate grounds .

I have a question for the FDA .

Why does the FDA think it's ok to provide ryoncil to the kids and adults under EAP
( when they have question about the assays) ???
but at the same time the fda have not approved same Ryoncil ( because they are waiting on new assays ) even after the amazing results that have been proven ... during phase 3 trials and also with the tsunami of real world evidence provided by the data from the hundreds of kids and adults treated with ryoncil under the EAP under compassionate use ..

surely blind Freddy can see that lives are being saved at the same rates as the phase 3 trial

should that not prove that our inventory is consistent ..

surely the FDA is on the verge of an approval very soon , at least for kids initially ..

note I do not begrudge EAP use but if it's good enough to save lives under EAP it should be good enough to approve ...

seems like hypocracy to me