RE: RE: Phase I clinical study, expected to commence in 2023.22 Nov 2023 14:04
Actually find myself agreeing with Stu.. which I dont like but Vlad recently wrote the RNS knowing what was required. I dont know who it was broke down the IND submission and what is required for PQ etc but it was made clear that much of the testing and certification was to do with the equipment, processes, training, documentation etc. Changing one part of the CAR-T does not invalidate all that work and does not require the same time or level of testing as when you first do the pre-IND runs.
Time will tell, I dont know how far along they are and when exactly they will re-submit or if they will or will not RNS. Nor do I know how long the FDA will take to respond. I believe it will be 2023, but if it slips into 2024 then so be it.
I am sure there are many who sold believing it would be a long wait and SP would drift south before and are probably hoping for a placing first. I know for a fact that some sold on the 28/29th September expecting an imminent placing and have been pretty peeved ever since as nobody wants to lose money in a trade.
But... as stu(wash my mouth out) says, "You either believe the company statement above or you donβt."
If you believe that IND will be approved by EoY then its a very short window and bickering on here is irrelevant, RNS is king.
If you dont believe the company statement then wait on the sidelines pray for a placing and hope its discounted, wish for no other updates on CBR etc and maybe you will be able to buy back at 2p or lower so your smart trade is vindicated..... However if you are one of these people, why would you want to buy in anyway?
If you dont trust or believe Hemogenyx why would you ever invest under any circumstances, why would you be on this forum? You would only buy if you believe company is going clinical and reality your just hoping for a small slip into 2024 to let you get a trade away...... Taking a huge gamble on no RNS and slipping by a few weeks into 2024 for a tiny difference in SP, honestly makes no sense to me but to each their own.
Off for the day, GL all!