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buckysherm

06/22/18 9:47 AM

#23721 RE: finesand #23719

Cydy / fda is talking outta both sides of their mouth. It “is” rolling BLA, but they have to submit all the safety data first, and they have to submit the complete application first. Effectively it isn’t BLA.

Northstar42

06/22/18 9:53 AM

#23722 RE: finesand #23719

Agree with everything in your post, but IMO MONO enrollment is higher than you estimated.