Friday, July 21, 2017 4:54:47 PM
with or without the lawsuit, that is the best they can achieve at this point. They need to partner and name a US manufacturer and get them approved BEFORE they can achieve a final approval. once they announce that, the 30 month stay is still the last remaining obstacle.
The litigation is a small non issue in my opinion. they can settle if they wish, they can fight it as they currently are and they already asked the Judge for preliminary motions to lift the FDA stay. I expect the judge to render his decision on the motions after the hearing set for the 26th of July. (the judicial hearing not the adcomm, they are both the same day ironically) however, its on his schedule and his discretion. but if he grants their motion, the only thing holding them up is the lack of a partner.
I hope that clarifies the issues.
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