I'll was intrigued by your post and what is a minor CRL.Whilst...

I'll was intrigued by your post and what is a minor CRL.

Whilst it is a positive from a FDA clarification perspective, it can be more substantial than a labeling change, it can also target nuance in bio equivalence data, manufacturing process and all elements that comprise the bridge that we much build being our ANDA v the brand dossier. The minor element just means its below a FDA threshold.

Forget Jublia because at Jetrodder points out no one get approval until patents expiry or there is a legal outcome in the case V Bausch. We have settled which to me means we are happy for others to spend $$ on the legal fight, good tactic.

Our partners are currently marketing approved FDA products, so they are a known commodity to FDA I worry about the detailed data in the submitted dossier regarding our chosen CMO's, scale up manufacturing process and think maybe this is the delay. All supposition of course but in the absence of com[any communication what else is there ?