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As much I was like Cytodyn to be mentioned, I don't believe it will be the case. Everytime that Trump mentions an antibody treatment, a lot of people on this board flip out and assume that it's us, or that we are going to have some after-hours announcement.
In this case it's most likely going to be Regeneron and Eli Lilly, there is no evidence to suggest that it will be Cytodyn.
Thanks for the clarification, that is helpful. I guess we will find out soon enough?
That's a good question, I am not sure which date they used as the true submission date, is it then or is it when they sent the PR about the BLA Acknowledgement letter? I don't know what date they picked, but I guess I am just saying that we can't be 100% about Friday, especially during a pandemic, I am currently in the biotech industry, we submitted our BLA in December and have already had our inspections delayed three times, despite the typical time tables for review. So unfortunately not all of these dates are set in stone.
PDUFA date is not a certainty. Even Nader said himself that they "hope" the PDUFA date will be announced on the 10th. It seems as though everyone here is CERTAIN that will happen. Unfortunately, the FDA is back-logged on everything right now that isn't Covid related and the HIV BLA is NOT Covid related. I also hope that it comes on Friday but we need to be realistic and stop dealing in absolutes. If it doesn't come Friday, it doesn't mean the sky is falling.
Potentially, but most likely they will still need a PLI, might just coincide with a biannual inspection. i have worked for a contract manufacturer that already had a PLI for an approved product, yet the FDA still required a PLI for the next product that we submitted a BLA for. But you might be right.
I think we need to check our expectations a bit. I personally don't believe the FDA is actively trying to hinder Cytodyn. The process of drug approval is complicated and fluid. The FDA has to gather as much information as possible to make an informed decision.
My company is also currently in the process of a BLA (submitted in January) and the FDA asked for more data as of March (and our trial has been actively treating participants for 5 years), it happens. Doesn't mean they are trying to prevent us from getting to market, just means they want to be sure before people start paying to be injected with our medicine.
Another thing is the PDUFA date. I hope it will be as soon as possible, but the FDA is very back-logged. Once again my company filed in January, and the PLI (pre-licensing inspection) was scheduled for April, then delayed until June and then delayed until September. Doesn't mean Cytodyn WILL be delayed, but they might. Unless the FDA decides to give them emergency approval for COVID. And they will have to do a PLI for both AGC and Samsung so it might make it a little dicier.
I like the optimism on the board but we shouldn't get too carried away. I have been long since 2018 and I am excited as well, just trying to stay somewhat grounded.
I think I’m telling myself that so I don’t lose my mind haha happy birthday! I definitely thought it would rip, but luckily we got a whole lot of week left
Unfortunately BLA submission doesn't mean approval. It's a huge step in the right direction, but we are still months away from approval and revenue. It will get there!
Exactly, and didn't they do the same thing when they announced the Vyera deal? it was during the CC and the PR'd it during the call or right after? Maybe I am not remembering correctly
You are 100% right bionerd, and it seems as though manufacturing hasn't begun or at least hadn't begun as of a couple of weeks ago. I believe that 2 months is a pipe-dream, the upstream process (cell culture expansion) takes about 2 months, the downstream process 1 week, but then it has to be release tested, sent to a finishing plant for bottling in vials and then shipped. So I think you're looking at a minimum of 3-4 months and that doesn't include supply chain for running a batch.
I am really excited about leronlimab and have been invested since 2018, but they are going to be low on product for a little while. Either way, still exciting to be in with CYDY. GLTA!
Maybe "amnesia" isn't but FEVER is and if you have ever had a high fever, then you would know that it can be accompanied by some consciousness issues
Yeah, it is weird that she says that, maybe she just doesn't understand that it is the molecule? Or it just sounded more interesting for TV, but they are definitely manufacturing leronlimab.
AGC manufactures leronlimab fully
Likewise! Hope they currently have batches working so they can get it to the patients ASAP
A batch takes approximately 10-12 weeks
Fair enough, thanks for the reply
I completely agree that is is a game changer, I have no doubt about that. I was just interested as to why you release info about a deal that isn’t complete if cancer and other indications are truly the endgame?
Why not just wait then until it is finalized?
This is my first post, been watching for awhile.
Just curious what advantage there would be to releasing a letter of intent versus an actual agreement?
They just trying to capitalize on Coronavirus before it’s over?