RE: WHO EUL7 Jul 2020 21:45
Once you get FDA , it does not take long to get approval in India. See NCYT (Novacyt/Primerdesign) on the list. They got their FDA 20/03/2020 and India 26/03/2020. This explains why genedrive is not showing on the India application list. They're taking a different route to get to India via FDA. Could they have done both? may be
CE Mark seems to have been dished out without much validation which is why we have so many cr@p tests out there. The CE Mark does not hold a lot of weight it seems. It certainly did not make a difference SP wise for GDR and ODX. Both dropped on CE approval.
About 1 month ago, i read somewhere that the FDA approval will not be as easy as it used to be as so many cr@p tests were in the US. Esp the antibody tests which had little accuracy but were on the market in the US.
Depending on when it was submitted, i would say in good time, it should be approved soon and we'll see the ball rolling then. Like TS said, they would not wait to line up buyers until the approval arrives and they would have done that.
ITS ALL ON THE fda - once we get that, we move forward.
I would have expect sales in Africa with the CE Mark.
As for WHO, not even submitted the application it seems. Not a target for GDR at the moment it seems. Again, why have they not submitted an application, God knows.
PS, for ODX, we saw an approval on this site a day before we got the RNS. It was on twitter before an RNS notified market.