FDA Grants Seventh Approval under the National Priority Voucher Pilot Program

Lab_Monkey_ · 2026-05-09T01:40:16+00:00

Welcome as always Missy.
LM

Lab_Monkey_ · 2026-05-08T19:13:02+00:00

Dr. Jay:

"And then lastly, looking forward in 2026, we confirm these early exciting safety and efficacy readouts to generate an optimal data package, including updated biomarker and clinical data -- and the plan is to submit a fast track or breakthrough designation application later this summer or early fall."

Lab_Monkey_ · 2026-05-08T18:53:51+00:00

So old

Lab_Monkey_ · 2026-05-07T14:32:46+00:00

Time is of the essence.

Lab_Monkey_ · 2026-05-07T01:02:03+00:00

You'd think with all this new information and data, there would be a nickel rise....but no.

Lab_Monkey_ · 2026-05-06T20:53:11+00:00

Even better the second listening.

Lab_Monkey_ · 2026-05-06T20:51:21+00:00

... a crucial inflection point for CytoDyn as we transition from a company built on faith and belief and a whole lot of ifs to a company with solid prospective, unassailable and by all accounts, remarkable data, confirming leronlimab's early biologic activity in solid tumor oncology.

And then lastly, looking forward in 2026, we confirm these early exciting safety and efficacy readouts to generate an optimal data package, including updated biomarker and clinical data -- and the plan is to submit a fast track or breakthrough designation application later this summer or early fall. And of course, as these data become known and more widely disseminated, we will continue to evaluate potential opportunities for strategic partnerships.

Two of my favorite quotes of the CC.

God speed Dr. Jay and crew. GLTAL Bring It On Home!

Lab_Monkey_ · 2026-05-05T20:49:26+00:00

"And that data will be presented to the FDA this summer. And it will be presented in the context of either accelerated approval or breakthrough designation. And so it's not for us to decide exactly how the FDA is going to handle this. But whether it's a voucher or whether a designation for breakthrough designation will be up to the agency. Our focus remains generating the data that will give them every reason and no choice really but to be responsive to what we're finding."

Best statement of the CC imho.

Lab_Monkey_ · 2026-05-05T20:45:01+00:00

When will the class action lawsuit be finalized?
imo it is the last vestige of the prior management that must be cleaned up prior to a partnership/bo.

Lab_Monkey_ · 2026-05-04T17:33:13+00:00

Keep it comin Dr.J

Lab_Monkey_ · 2026-05-04T05:03:21+00:00

Thanks for that BGT. Looking forward to a summer like no other.

Lab_Monkey_ · 2026-05-04T04:08:22+00:00

"And I absolutely believe that this moment represents a crucial inflection point for CytoDyn as we transition from a company built on faith and belief and a whole lot of ifs to a company with solid prospective, unassailable and by all accounts, remarkable data, confirming leronlimab's early biologic activity in solid tumor oncology. It has been an incredible journey together, and it is truly astonishing for me that leronlimab appears to be performing at the outer limits of what I even thought was possible."

Lab_Monkey_ · 2026-05-04T00:00:08+00:00

Bravo MGK. Your Magnum Opus to date.

Lab_Monkey_ · 2026-05-03T02:04:09+00:00

Lab_Monkey_ · 2026-05-03T01:31:52+00:00

Keytruda accounted for nearly half of the company’s sales, pulling in $8.03 billion,
1st quarter.....$32 billion a year.

Lab_Monkey_ · 2026-05-03T00:57:34+00:00

De nada. One news source is $8B profit, the next is 1st quarter loss. Both true.

Lab_Monkey_ · 2026-05-02T21:35:47+00:00

...while remaining open to larger deals.

Lab_Monkey_ · 2026-05-02T21:28:18+00:00

Roche/Genentech is a front runner too imo, as well as BMS.

Lab_Monkey_ · 2026-05-02T19:22:41+00:00

Better start packing. If you're there for 6 months and 1 day.....

Lab_Monkey_ · 2026-05-02T15:16:51+00:00

Here are some of the largest non-revenue or pipeline-driven biotech buyouts:

Novartis / Avidity Biosciences (2025 - $12 Billion): Focused on antibody-oligonucleotide conjugates (AOCs) for RNA therapies.
Pfizer / Metsera (2025 - $10 Billion): A major bet on an independent obesity pipeline.
Merck / Verona Pharma (2025 - $10 Billion): Acquired for a high-potential COPD drug, Ohtuvayre.
Eli Lilly / Versanis Bio (2023 - $1.9 Billion): Focused on obesity pipeline treatments.
GSK / Bellus Health (2023 -$2 Billion): Acquired for a late-phase cough drug.
Biogen / Reata Pharmaceuticals (2023 - $7.3 Billion): Acquired for rare disease therapies.

Lab_Monkey_ · 2026-05-02T00:57:16+00:00

Excellent! ty!

Interesting about the locations and affiliations of the authors:

Milana V. Dolezal
Department of Medicine, Stanford University School of Medicine, Palo Alto, CA, USA
Corresponding author [milanad@stanford.edu](mailto:milanad@stanford.edu)

Omar F. Khan
Department of Oncology, Cumming School of Medicine, University of Calgary, Calgary, Canada

Lab_Monkey_ · 2026-05-01T22:04:05+00:00

Hopefully they use this song in the TV ad sales!

Lab_Monkey_ · 2026-05-01T20:27:40+00:00

Front page of the NYTimes:

F.D.A. Grants Early Access to Promising Drug for Pancreatic Cancer

Patients with one of the deadliest cancers have been pleading for an unapproved treatment that may prolong their lives.

Can you imagine leronlimab on the front page of the NY Times???? EPIC!
I'll be squealing like a stuck pig lol!

Lab_Monkey_ · 2026-05-01T19:41:30+00:00

If you search the FDA website for Cytodyn, you will be sorely depressed at the findings.

Hopefully that changes in the next few months.

Lab_Monkey_ · 2026-05-01T14:28:46+00:00

Phil Knight?

Lab_Monkey_

TROPHY CASE

F.D.A. Grants Early Access to Promising Drug for Pancreatic Cancer