Replies to post #164645 on Cytodyn Inc (CYDY)

[DonDonDonDon]

And lenzilumab has no drug even to use if they need too , per CEO recently ..

" we AIM to have 100,000 doses in 12 months "
this equal to about 33,000 patients , since each need 3 doses.

We've been through this several times. Cameron Durrant has specifically said 100,000 patients in 12 months several times. Here is where Reuters quoted him from the conference call: "We are scaling up our manufacturing and we hope to have enough therapies to be able to treat 100,000 patients over course of the next 12 months," CEO Durrant said. Durrant always gives conservative estimates so it'll likely be a much larger amount.

https://www.reuters.com/business/healthcare-pharmaceuticals/humanigen-says-drug-improves-ventilator-free-survival-covid-19-patients-2021-03-29/

[DonDonDonDon]

But why did they need a special design by NIH and FDA

HGEN received special treatment because scientists in the FDA and NIH believed lenzilumab would work. They believed that GM-CSF was the cytokine responsible for the the cytokine storm. Turns out, they were right.

https://www.bbc.com/news/health-56352128

[DonDonDonDon]

Why did they need a special design by NIH and FDA , if they don't even have enough of drug.

Companies normally wait for the EUA before they start mass production that way they don't get stuck with 1.2 million vials with no where to go. HGEN is part of Operation Warp Speed, BARDA, and CRADA. The government has promised manufacturing resources if lenzilumab gets an EUA. Humanigen has $240 million in cash to start mass production. The EUA is the beginning, not the end.

https://www.biospace.com/article/releases/humanigen-announces-the-addition-of-barda-and-expansion-of-crada-with-the-u-s-government-to-develop-lenzilumab-for-covid-19/

[Grip it and Sip It]

Well, sounds like a great case for a new CEO with experience and “juice” with the FDA. Unfortunately, once a CEO loses credibility, which Nader has, shareholders pay the price!

Best to you

IMO of course

[DonDonDonDon]

" we AIM to have 100,000 doses in 12 months "
this equal to about 33,000 patients , since each need 3 doses..

HGEN released a 10-Q yesterday. It says they spent $51.7 million in manufacturing in the first quarter and will spend at least that much in the second quarter. That is $103.4 million already committed to manufacturing. By my estimates, one lenzilumab treatment costs $100 to manufacture. So that is one million treatments already being made. One million times $10,000 per treatment is $10 billion in sales. And that is just manufacturing paid for in the first half of 2021. Not bad for a company with a market cap of $1 billion.

Also in the 10-Q it said that after having a guidance meeting with the US FDA, HGEN will apply for an EUA by the end of May. The US FDA almost always gives an EUA when they greenlight the application. The US FDA told CytoDyn "thanks, but no thanks" to them applying on both of their trials.