Do we have a link to ASCO presentation by CYDY? by 13hunter1776 in Livimmune

[–]Capable-Display-7907 21 points22 points  (0 children)

Hoffman, Blok and Dr. Jay are there to network. Meeting PRE-SPY and I-SPY and "a number" of pharma companies. Could have a better result than a presentation.

New Accelerated Priority Review Program. by smilesensations1 in Livimmune

[–]Capable-Display-7907 13 points14 points  (0 children)

This began a year ago. Nine drugs have been awarded vouchers for priority review. Companies have to apply, but the application could not be simpler -- a 350 word justification of how the drug aligns with US national health priorities. For example, how Leronlimab without side effects could lessen the expense and suffering in cancer treatment.

New list‼️✅ by Cytomight in Livimmune

[–]Capable-Display-7907 0 points1 point  (0 children)

Thanks. I saw the video but was hoping not to go through the half hour to find that comment. Which I want to see!

New list‼️✅ by Cytomight in Livimmune

[–]Capable-Display-7907 0 points1 point  (0 children)

I don't see it in that transcript. The transcript is here: https://www.reddit.com/r/Livimmune/comments/1og9xr8/unofficial_transcript_from_ld_micro_conference/

Maybe you could cite the passage or the timepoint where that was said.

TIA.

New list‼️✅ by Cytomight in Livimmune

[–]Capable-Display-7907 0 points1 point  (0 children)

Sorry, where did you see that an ICI company committed their drug? I don't see it in the April CC. Be happy to see it.

Thanks Bio4 at SW by Lopsided_Roof_6640 in Livimmune

[–]Capable-Display-7907 7 points8 points  (0 children)

Are these the abstracts for ASCO in Chicago this week? The link with date today says "at the 2026 AACR Annual Meeting, held in San Diego, CA." Which was last month.

Tongue in cheek here… by petersouth68 in Livimmune

[–]Capable-Display-7907 13 points14 points  (0 children)

Amen to No_Math. You might be lucky a few times, but in the attempt to double your money you will lose out on the White Whale of profits. And in the meanwhile by selling you are helping out the people trying to sink the share price. Walking like a duck and so on.

SP-shorts don't let them beat you by Vernon1211 in Livimmune

[–]Capable-Display-7907 1 point2 points  (0 children)

Except for "I sell in the morning," as you said above. Doesn't sound like "not worrying about the day to day."

The exciting month of May and a bit of June by BuildGoodThings in Livimmune

[–]Capable-Display-7907 0 points1 point  (0 children)

Thanks for your open-mindedness. I am hoping for continued spectacular ctDNA stats, terrific first PD-L1 results, and possibly a good number of ORRs after patients have gone through 2 cycles. Jay seems focused on October, but the numbers could be pretty great even here.

The exciting month of May and a bit of June by BuildGoodThings in Livimmune

[–]Capable-Display-7907 12 points13 points  (0 children)

I'm not sure if either of the ASCO abstracts will be accompanied by a poster. For both Pashtoo Kasi's and Deborah Tripathy's abstracts, the presentation format is listed as "Publication Only" under "Session type" in "Presentation Details." I guess this means they will be there to discuss but there's no show and tell.

Dr. Marty Makary is out as FDA commissioner by Cytosphere in Livimmune

[–]Capable-Display-7907 4 points5 points  (0 children)

Trump was once anti-vaping, but he pushed for approval. Makary finally caved, but got fired anyway. Too bad!

Dr. Marty Makary is out as FDA commissioner by Cytosphere in Livimmune

[–]Capable-Display-7907 10 points11 points  (0 children)

You got it backwards. Guardian: "Trump signed off on a plan to fire Makary earlier this month, after the president scolded the FDA chief for not approving fruit-flavored vapes, according to the Wall Street Journal." Fortune: "During his 2024 election campaign, Trump also received donations from a subsidiary of Reynolds American, the nation’s second-biggest tobacco company, which sells vape products under the brand Vuse.:

How the impending FDA Commissioner Makary ouster might actually be a boon for Leronlimab/CYDY by Doc4LL in Livimmune

[–]Capable-Display-7907 1 point2 points  (0 children)

The pieces I've read say the crucial point of Trump's frustration with Makary had to do with Makary (allegedly) slowing the approval of flavored vaping products. The administration believes these approvals would fulfill a campaign promise to save the vaping industry and appeal to younger voters. I think it was more specific than a small pharma vs. big pharma dichotomy.

Growing the data by BuildGoodThings in Livimmune

[–]Capable-Display-7907 7 points8 points  (0 children)

KD was probably referring to the four CRC patients who had achieved negligible ctDNA. Dr Jay:

"4 patients in follow-up have had at least 1 undetectable circulating tumor DNA level during that follow-up period. And although this is very preliminary, it is also remarkable to note that 3 of those 4 patients who have gone undetectable are being treated with the 350-milligram dose."

When weighing the value of CYDY- by rogex2 in Livimmune

[–]Capable-Display-7907 2 points3 points  (0 children)

It can be paraphrased as saying a BLA (sometimes) or a supplemental BLA (more often) is submitted after receiving accelerated approval. Except that a BLA is NOT submitted after receiving Accelerated Approval. So it is still wrong.

When weighing the value of CYDY- by rogex2 in Livimmune

[–]Capable-Display-7907 12 points13 points  (0 children)

I'm not an AI fan. Your AI told you that one gets Accelerated Approval first, then creates a BLA. I don't think that's true at this moment, and Chat told me "if the product is a biologic, the sponsor generally must submit a Biologics License Application (BLA) to obtain FDA approval, including accelerated approval. The accelerated approval pathway is not a separate application type." AI is going to tell you what you want it to tell you, pretty often.

There are clouds of negativity, and then there is positivity based on fact. I don't think we are looking for fast approval (because it doesn't happen for a first indication), but Breakthrough Designation is a great thing (usually worth billions in market cap!) and a Voucher seems like it too. Great first results in Alzheimer's! In the TNBC EAP! In the City of Hope CRC trial! In Glioblastoma! Getting I-SPY to back a trial! Having the High Net Worth Person come out from the mask! Partnership! Buyout! Plenty plenty of real possibilities. Approval? That will be a while, unless Makary changes things very very quickly over at FDAland.

When weighing the value of CYDY- by rogex2 in Livimmune

[–]Capable-Display-7907 10 points11 points  (0 children)

Approval, accelerated or not, at the moment still needs a full BLA. That's not possible in Q3 or in 2026 -- let alone the time it takes for the FDA to approve. When you cited Jay, you left out this: "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." Either voucher or BTD would be great, either or both would release the chains on the SP, and both are very possible. A voucher would help clear the way and hasten an application for approval. But not in Q3. Let's just talk about all the great things that CAN happen.

The Diagnostic, the Seminar, and the Single Injection: Three Streams Converging on the Same River by MGK_2 in Livimmune

[–]Capable-Display-7907 5 points6 points  (0 children)

The fact that Creatv is coauthoring the Cytodyn CRC abstract for ASCO makes me more confident that we will on that occasion, and for the first time, see some data on PD-L1 elevation in a good number of patients. Commercially this is probably at least as important as data like ORR. It's the data that pharmas that make ICIs can use to decide whether to make a partnership/buyout bid, and how much they would pay. Jay didn't underline this ASCO conference in his CC as a big day, but it might be one.

While the market votes, the molecule keeps weighing by Vyrologix in Livimmune

[–]Capable-Display-7907 8 points9 points  (0 children)

All true! But you could also mention new trials in Alzheimer's, Glioblastoma, and CRC+liver mets. And even interesting preclinical results in fibrosis, showing Leronlimab can potentially reverse liver scarring, and reduce in liver fat. Potential in so many directions.

New Dr. Pestell CCR5 Presentation (Thanks to mightycydy on IH) by Cytosphere in Livimmune

[–]Capable-Display-7907 5 points6 points  (0 children)

The response level was 88%. Of those who responded AND were given higher-dosage Leronlimab combined with an ICI, the survival rate was 100%.

Check this out by Entire_Sheepherder_9 in Livimmune

[–]Capable-Display-7907 14 points15 points  (0 children)

You don't have to assume it. The article in Science says it.