RE: Re: PLAN7 Sep 2022 20:08
well darth my thoughts as to why they might want to wait for fda approval before marketing,mainly centred around the idea that this might make uniformity of marketing and promotional material easier to achieve across the board. they have said they wish to build a global brand( or words to that effect) and with the fda trial in th bag i would suspect it might be more straightforward to standardise promotion. this is a rather vague and largely amorphous thought and probably wrong, but it has remained with me as a result of the discussions about whether they can say "clinically proven". i really don't want to go over all the arguments again on here,as they have been done to death over on advfn and so far as im concerned there is no mileage remaining in the discussion. that said, if there is substance in the argument that they cannot reliably use "clinically proven" just on the basis of the ce mark, then hopefully any doubts about this would be removed by a successful fda trial (even though technically not a P111 as such). im just thinking aloud really and certainly don't hold any categorical views one way or the other. the other factors you mention would certainly seem to militate towards a launch asap, but it may just be that as the fda trial seems to be progressing slightly faster than they might have expected (i was pleased to see the headline results announced a little earlier that expected )they might just feel it is better now to wait for the full trial results.hoping matters may be clarified a little next week.