RE: Is a leak possible?5 May 2022 14:24
with the FDA submission within an "administrative phase" you would think that a refusal on our submission would be pretty low. nothing is 100% but FDA wouldnt spend more time/ resource over the submission if they ever thought to reject it one would think.
within the telegram page it has been mentioned that there are only up to 4 live submissions through the denovo process thats awaiting feedback from 2020 submissions, were one of them. thats out of a figure of 64(using this figure off memory so maybe slighty different)
its coming and my best guess would be before end of june. just a waiting game now. and looks like plenty of buyers taking up a position or adding to their position about to test previous highs around 140