Replies to post #86632 on Cytodyn Inc (CYDY)

[$5.95akadawson-m]

PR on 5/13/20:

CytoDyn completes all remaining parts of BLA for leronlimab CytoDyn confirmed on May 11, it submitted all remaining parts of the company's Biologics License Application for leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients to the U.S. FDA. Pursuant to FDA guidelines, CytoDyn informed the FDA it had submitted a complete BLA for rolling review. As a next step, the FDA will start reviewing the BLA for completeness and will make a filing decision. After the BLA submission is deemed completed, the FDA assigns a Prescription Drug User Fee Act goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA, and the company plans to request a priority review for the BLA. A priority review designation, if granted, means the FDA's goal is to take action on the application within six months of receipt.

Read more at:
https://thefly.com/landingPageNews.php?id=3092832

[Tomand1]

Where is the documentation proving it was not submitted?

Remember no links no proof, no facts.


I am 99% sure it was submitted since NP went on record saying it was and thus would be liable if it’s not, this would also open the door to and SEC investigation if he was lying. So since none of that happened it’s very safe to say it has been submitted.

Where is such proof that it wasn’t submitted. As of now there’s far more evidence saying it was than it wasn’t

[bluefish1]

There's no documentation available to look at. For your reading pleasure...

No documentation does not equal no application. It isn't just what Nader said. It's the fact that when he says it, he speaks for the company. That's the law. If he says it, and he's making it up, that's a violation. He subjects himself and the company to fines and penalties. Not happening. Myth busted. FDA would have already taken action at this point.

Requirements Applicable to Drugs and Biologics in the United States

In the United States, the Food and Drug Administration (FDA) regulates drugs and biologics under the Federal Food, Drug and Cosmetic Act (FDCA), the Public Health Service Act (PHSA), and implementing regulations. Section 505 of the FDCA prohibits the introduction of a new drug into interstate commerce without an FDA approved application for marketing authorization under either section 505(b) or section 505(j). Applications under FDCA section 505 include the new drug application (NDA), the abbreviated new drug application (ANDA) and the “505(b)(2)” application. Section 351 of the PHSA imposes a similar requirement for biological products. Applications under PHSA section 351 include the biologics license application (BLA) and the biosimilar application.

The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the development process, approval process, or after approval may subject a company to significant sanctions, including refusal to approve pending applications, withdrawal of an approval, clinical holds, warning letters, product recalls, product seizures, injunctions, fines, refusals of government contracts, restitution, disgorgement, or other civil or criminal penalties.

[Blane]

Please....

The company itself released a statement as such. It wouldn’t just be NP making the statement if it’s on the website. That is common logic.

When the fda responds and the share price moves again, what will your argument be then? Do you ask the same questions every time Gilead puts out an fda statement? If not, that would be a double standard.

Here’s the link by the way. But I really don’t need anyone’s ‘acknowledgment’ outside of the fda or company press releases to believe it. Because that’s all that is necessary.

https://www.cytodyn.com/newsroom/press-releases/detail/437/cytodyn-receives-bla-acknowledgment-letter-from-the-fda

See you in December! It’s already a ten bagger! LMAO!

Oh... and I’m sure the fda just allows companies to make statements about submissions lightly. LMAO!

[diogenes69]

BLA includes information from the trials, so obviously it is not available. The FDA is clearly complicit in this scheme. Nader payed them to play along, and they agreed to blind the results from the trials to fake everyone out. Everyone should be panic selling their shares right now.

[Amatuer17]

What documentation you see in other companies? Do you have example?
Most of the companies issue PR and that is taken as valid proof that company did that task.

[RationalBeing]

JDF "Where is the DOCUMENTATION proving a submitted BLA?"
But, but, NP said,....period

per your new post 92956

"The Company filed its BLA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients with the FDA on April 27, 2020"

At least we got that out of the way

I need to add a side note, the original post made posed that question on 6/23/20, just about 2 months after (per your new post) the BLA filing. It just takes a little research, I guess.