IMO, this is where Pfiffer earns his keep. Not just an attorney, but was 10 years as an FDA appeals official. He dealt with the CRL's and responses. IMO, if anybody knows the workings about how to respond effectively and has credibility with the FDA it's him. Personally, I would have liked him on the CC yesterday too, but what they can say may be limited.
Bngo It is very much a mystery of the FDA 2014 Tmax that would simply be a "Label and Directions Instructions" resolution to the current Jul 2016 "Safety Issue"
It is obvious that $ELTP has been shocked at the CRL Tmax as indicated by Nasrat tone in the Mon CC.
Best for all shareholders to listen again. Skip the first two minutes.