I have not read it nor seen a direct link. But a possible help may be to compare to similar drug Entereg which was required to perform MASE. Looking at retro studies, relistor appears to have a safer profile with non deaths. One may assume also cancer patients are more likely to have a CV event but that is presumptive. But based on all the info and the fact that Entereg has MASE data, and given relistor is similar, the FDA should be smart and allow PGNX to use similar restrictions as Entereg. I do however feel that PGNX could have been more proactive instead of sitting on their hands for two years.
ssddawg, stop with the non-sense. Entereg is NOT similar to Relistor. As far as the CRL, just what company ever releases the text of a CRL? None of them do. They should be made to do so, but they aren't required to do it so they don't do it.
Apologies. Allow a few corrections.
One would not want same restrictions as Entereg, Entereg is only in-patient (hospital) use for post-op bowel resection ileus, and short-term. No outpatient cash cow and no long-term use.
I am not sure how PGNX will convince FDA to get approval to use relistor outside of non-cancer OIC, RIght now Relistor appears to be in a better position than Entereg. Now throw in Naloxegol into the mix as well. Not sure exactly what to make of this all.
Perhaps management will be kind enough to shed some light on the AdCom and other pipeline issues. Again, apologize if I made any errors.