recent RNS10 Dec 2020 14:39
afternoon bucolic.i hope you are well and enjoying today's lively board.yes lets see what develops.i haven't posted for a while but for what its worth(not much probably)i actually found the last RNS very encouraging and was surprised how little comment it got.i accept that in a sense it did not tell us a great deal that we didn't already know,but i think that assessment is a little superficial.first it provided for me some definition to the FDA process,with a clear timeframe for the next formal stage.i also found the reference to the feb meeting as being "to agree details primarily relating to the statistical analysis plan" quite interesting.whilst not wishing to read too much into this and acknowledging the word"primarily", it does seem to suggest a relatively narrow focus for the outstanding issues.just my take of course.you would expect detailed planning and preparatory steps to be continuing but nice to have it confirmed.also i was encouraged by the EMA aspect.first it gave the lie to the suggestion made recently that the ema probably haven't even started looking at the technical file.how far along the way they are we don't know ,but they have started scrutiny.i was particularly intrigued by the talk of exclusive negotiations for one specific region.may come to nothing of course,but intriguing nevertheless.sorry for going over old ground,but i really did find it encouraging.