RE: 2nd FDA pre-submission meeting5 Jul 2020 21:48
bald eagle my apologies, at least for using the word" fixed,"which you did not. i was reading something that was not there. however I've listened again to the james presentation at the period you quote and unless my hearings is as bad as my eyesight, he does not say it it was estimated take place in july. he talks about the request for an additional meeting and then says words to the effect that if all goes well they would expec to file in september.no mention of july as such.unless I've missed it.anyway clearly it should take place in july or august at some point so not really much point worrying about it till we hear. yes of course it fum need additional data for fda it will be a hurdle they will have to overcome,.they have been completely transparent regarding this possibility (the same possibility exists relation to the EMA application although fum seem to regard this as less likely). that's just the risk you run with this type of thing. if they announce the fda need additional data the s/p will probably take a hit,just as it will probably be boosted if they announce no additional data is required. hopefully all current and potential investors realise this. if they do find that additional data is required for fda but say not for EMA they might well decide to run with the EMA first and get one approval under the beltas it were, but we are now going onto the realm of pure speculation ,so I'm comfortable with just waitingto see what happens.