RE: Take Care19 Mar 2021 19:08
whilst I'm all in favour of caution,i have the following comments/
1/once the notified body has recommended certification the formal approval is, i believe, just that.a formality.it will be granted.
2/med 3000 is likely to appeal(inter allios) to those contraindicated for cialis and similar drugs.it is not a drug,but a device.
3/perhaps you are not familiar with the history here,but the general understanding is that it is very cheap to produce.
4/we already have the china deal of a few days ago and todays rns refers to several offers .i do not think there will be any difficulty in concluding a deal. obviously we do not yet know what the terms will be and that will.of course,be critical to the next step in the s/p movement.
i agree that, as always, caution should be exercised ,but i think the picture is a little more positive that your post suggests.i do think caution needs to be exercised in relation to the market size, but this is where i have been encouraged by the chinese deal and was further encouraged today by the statement about fast track approval in other regions,e.g. latin america, as i was not previously aware of this possibility.
also,and this is just my personal take on matters, the Notified body appears to have approved the data package pretty quickly as these things go (personally i was expecting it to take longer) and seemingly without any particularly arduous and exacting requests for further information. this suggests to me that the FDA passage may be reasonably smooth. just speculation on my part,but with some basis for it i think.