Thanks for the informative post Jetrodder - you have added great...

Thanks for the informative post Jetrodder - you have added great insight into this forum over the years.

Anyone have thoughts on when the FDA will grant approval for the 3 submitted drugs? I'm sure further licensing deals are in place and products will launch as soon as FDA give approval.

Below is a snip of August investor presentation. I did not pick up on the first footnote in my original read (the first one was very small!!!!). I had no idea the ANDA was only accepted for review in August 2020. So 10 months from August 2020!! Hopefully the other 2 are nearing approval.


Footnotes through out the presentation
* Acrux submitted its ANDA for a generic of EMLA® to the FDA in June 2020 and the dossier was accepted for review in August 2020
As at August 2020 there are currently 10+ dossiers submitted to the FDA for a generic version of Jublia® with none commercialised