Monday, June 18, 2018 9:29:53 PM
my bla bla simply reiterated where we stand and market doesn't follow yet, that's OK for now.
FDA discussions surely conclude with the BLA filing, only how they will do it may give a surprise.
- Priority Review
- Rolling BLA
in the end, company is 'just' falling into Combo approval and about to pick up its 1st big market-size, no matter what.
Melanie Thompson's review discussion on our blog site also surprised me positively, since 01 & Co took apart her negative Combo market-size complaint, which sort of contradicted herself. Other than that she still seems to be quite positive, maybe also a little bit tired waiting for some approval (o8>
Sure, we like to see Monotherapy's high dosage arm to be agreed upon as well. Chances are good it resolved some issues in combination with patient selection - evidence.
Wonder about Misiu's opinion here.
Maybe after SP is corrected enthusiasm kicks in again, but until then - yawn & waiting.
Maybe they need to receive a Nobel price or something like that to get some attention (o8>
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