While I agree with Adherent...I also understand that sometimes knowing ppl/contacts/experts can help.
I would answer yes to Rae915...Dr Skerrett has submitted multiple successful NDA's in the past...they have the two of the leaders in the entire space on our side batting for us just on the OA side (one of them is joint leading the FDA mandated OA Biomarker Consortium)...then add in T. Shnitzer and then R. Giugliani in the MPS space, world leaders. You think the FDA are going to ignore all that to protect some part of the industry?
Yes the data speak volumes and volumes on it's own...couple that with the immensely glistening and pristine safety profile and that's spades... but the greater KOL's and PGIC of the patients will only help. It will be a chorous, a litany as we progress.
My views.
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