RE: Operations Update- out Now8 Aug 2020 14:07
dougie whilst i agree that we need to read any statements by regent re intent or likelihood with a couple of buckets of salt, there is, i think, one scenatrio where it is just possible a potential licensing partner might wish to sign up before formal approval. normally i would agree that this is most unlikely, but here, supposing there were more than one interested party, then one of them might be wi ling to sign up before approval, say on the basis of a very modest sign on payment with larger milestone payments etc on approval. my reasons for thinking this is possible are that we are not dealing with something like an antibiotic or treatment for cancer or other diseases, where safety and efficacy issues frequently cause drugs to fail at the last hurdle. the successful switch from RX to OTC (about which i was always highly sceptical due to the rarity of success in this area and the relatively short duration for new data since the original approval) would suggest that safety data is very strong (possibly efficacy as well, although that has never really been any doubt in this area and this has been endorsed, i think, quite strongly by professional feed back). there is every reason to expect safety and efficacy data to be similar in the p2 and p3 trials, so licensees looking at matters may well feel that this is one of those situation s where approval is much more likely than not and as such might want to strike before rivals. we still have the question of whether the questionnaire will be sufficient, but i get the impression (just my personal take) that regent are fairly confident in that respect. so i think there are some grounds for, as i say, a modicum of optimism.just my opinion of course.time will tell.
Sign In
Follow the stocks
