RE: RNS10 Aug 2020 15:03
bald eagle my take on the ema process is thiss.first none of us have any real idea whether ema will require more data, thats obvious. that said i think there are some grounds for modest optimism that they may not.i think i am correct in saying that it has always been expressly contemplated by fum (always meaning since the start of the new MED3000 process) that a further date/trial was possible for FDA process.whilst not ruling out the same for EMA, fum have never suggested it was likely in the same way as they did expresslyfor FDA.now i know some people take the view that you get radically different guidance from the 2 authorities, but quite frankly i think that is just wrong.yes the procedures are different, but i have never accepted that fum would not have been give the fullest possible guidance for the ema submission.what the guidance cannot do entirely is to cover questions arising from the full data package once it has been submitted and considered.hence the possibility of further data/trial being required and it cannot be ruled out.however given the different assessments of initial requirements by fum my take is that they feel there is a reasonable chance of further data /trial not being required for ema and that this is based on the EMA pre submission discussions. anyone thinking of investing now should,imo,consider the possibility that further data may be required, but they would have to balance that against the risk that if they leave it to see what is required, they will pretty certainly be facing a higher (perhaps significantly higher buy in price if nothing further is required. also just on todays RNS, i agree with the comments by some that the QSM audit is something you would expect them to achieve (i expect the standards are quite high for a medical device but it is fums specialist area) so its a modest piece of positive news and another step in the right direction. what is interesting is the comments about specialist advisor etc. of course it could be a mere puff, but I'm prepared to give them the benefit of the doubt. the was no need (and indeed it might have been inappropriate )to mention it unless it indicated positive change to the pre-existing situation,so again i regard it as a modest (perhaps more than modest )indication of positive developments in the potential commercialisation field.just my opinion of course.
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