We certainly don't need any more delays with the resubmission being late September/ October timeframe. Add six months and all of a sudden we are in March for a new PDUFA. And that is only with 90% certainty from the FDA's own records.
My hope is at some point the behemoth which we know as the FDA recognizes this drug is needed. I have never heard Al say it might be possible if the drug is implemented early enough in the disease, it might be possible not only to slow down the progression, but to reverse the progress of the disease. The trials are non-inferiority but if the results demonstrate superiority our long awaited ship has come in.
Swing
