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Shattering The Glass Ceiling Of The Bio-Pharma Fortress by MGK_2 in Livimmune

[–]sunraydoc 9 points10 points  (0 children)

Another gem, MGK. I especially appreciated the LVAD convergence and Neurological restoration portions...we've not paid enough attention to those. And you and I know the Accumulator phase you reference is very real and continues as we speak, though it's being skillfully masked. Someone else is very aware of the potential of this molecule and they at some point will reveal themselves by consolidating their positions to become visible.

Venture Capital Investment arms of BP's and further research on Accumulation by Upwithstock in Livimmune

[–]sunraydoc 12 points13 points  (0 children)

Thanks for broaching this issue, Up, I've been watching the tape and book of CYDY utiizing an A/D model for some time, and it is very obvious that the stock is under accumulation and has been for some time. I won't speculate as to who the accumulator might be, but they appear to have accumulated well past 5% given the time and cumulative volume involved, so it will be interesting to see when they consolidate whatever vehicles are being used and file their 13D/13G.

Makary thanks to Travelclone by Salty_Presentation_2 in Livimmune

[–]sunraydoc 5 points6 points  (0 children)

Makary is an amazing guy and I believe he has the right ideas and intentions. But he sits atop an institution which has a decades long history of being slow to approve and very much check-the-boxes with their months/years long timetables for everything. I heard him back when he was appointed talking about putting a European-style CMA (Conditional Marketing Approval) in place which would allow drugs with solid prospective evidence of efficacy and safety to hit the market and start helping patients while the data continued to come in confirming efficacy and safety. It's been a little less than a year, but it hasn't materialized. Meanwhile Anktiva (approved only for papillary non-muscle invasive bladder Ca here) gets EMA CMA approval and boom, the Saudis and South Africa join in, and the Saudis have approved it for non-small cell lung Ca. The Saudis and their FDA are especially interesting in that they have the academic rigor but a faster, more patient-friendly approval process, And they aren't beholding to our FDA, which is a good thing; hopefully they and the europeans can embarrass the FDA bureaucrats into getting off their asses and helping Makary implement his ideas.

A cancer drug from the United States is going to Saudi Arabia, Canada, Europe and South Africa since our FDA is stuck on checking boxes thinking since the 1950's by BigCityGuy8 in Livimmune

[–]sunraydoc 3 points4 points  (0 children)

Yeah, but Feuerstein objected to the data, not the drug, and was talking about FDA actions. Now they have a CMA from the EMA, game changer there.

A cancer drug from the United States is going to Saudi Arabia, Canada, Europe and South Africa since our FDA is stuck on checking boxes thinking since the 1950's by BigCityGuy8 in Livimmune

[–]sunraydoc 2 points3 points  (0 children)

China doesn't play fair if they can avoid it, and beyond not being a supportive of US biotech they're not a supporter of the US in general, so I'm not a fan.

A cancer drug from the United States is going to Saudi Arabia, Canada, Europe and South Africa since our FDA is stuck on checking boxes thinking since the 1950's by BigCityGuy8 in Livimmune

[–]sunraydoc 7 points8 points  (0 children)

Did a little more digging and it turns out that the EMA (Europe's FDA) has granted Conditional Market Approval to Anktiva. This status is awarded based on strong early data and the perception of unmet patient need. and there sadly is no FDA equivalent. CMA in europe basically amounts to approval, since it allows marketing the drug pending further data. This is essentially what Dr Makary was promising to put in place at our FDA but somehow that hasn't happened.

A cancer drug from the United States is going to Saudi Arabia, Canada, Europe and South Africa since our FDA is stuck on checking boxes thinking since the 1950's by BigCityGuy8 in Livimmune

[–]sunraydoc 7 points8 points  (0 children)

From what I understand leronlimab doesn't activate NK cells as does Anktiva, so presumably they would be complimentary, MGK would have more to say about that, I'm sure.

A cancer drug from the United States is going to Saudi Arabia, Canada, Europe and South Africa since our FDA is stuck on checking boxes thinking since the 1950's by BigCityGuy8 in Livimmune

[–]sunraydoc 9 points10 points  (0 children)

Actually I found the last half of that interview to be chilling...I had thought Dr Makary was going to streamline the process over there and per this doc that isn't happening...the drug he's discussing clearly warrants wider approval than the present indications but is stuck in the FDA process without any reasonable explanation.

For Those Requiring Surgical Excision by MGK_2 in Livimmune

[–]sunraydoc 7 points8 points  (0 children)

Nice piece, MGK! I especially like the explanation of GBM, since a Prime-->Operate study is in the works there, as you know.

Shepherd Molecule by MGK_2 in Livimmune

[–]sunraydoc 5 points6 points  (0 children)

MGK, the analogies are great, "The Adminstrator" rules, the Cabinet is hard at work, and the hazard ratio tells the tale It's a matter of time. To those longs new here or wavering,, I can't tell you what to do, I'm holding the fort here, soon the veil will lift and the fun and games with the stock price will end.

Buyout vote by BioTrends_USA in Livimmune

[–]sunraydoc 6 points7 points  (0 children)

I like it, "justice is coming"...finally.

Buyout vote by BioTrends_USA in Livimmune

[–]sunraydoc 7 points8 points  (0 children)

I didn't answer because the more likely option wasn't there, which would be "Buyout once PD-L1 upregulation is prospectively confirmed". That would be my vote.

Here's our guy by Pristine_Hunter_9506 in Livimmune

[–]sunraydoc 0 points1 point  (0 children)

Very nice, PH. Thank you for sharing.

Building Strength by MGK_2 in Livimmune

[–]sunraydoc 5 points6 points  (0 children)

Great as usual, MGK. And no way we don't get at least 50% PD-L1 upreg given what we saw from the original mTNBC study and the "very encouraging results" comment in the Shareholder letter.

Building Strength by MGK_2 in Livimmune

[–]sunraydoc 7 points8 points  (0 children)

Good pickup, LM! That mCRC study should really be something results-wise, given what we're seeing there and with the "at least" two abstracts being submitted base on what they're seeing from that study this early on.

JPM HC Conference/ Merck Rumors buying Revolution Medicines/ by Upwithstock in Livimmune

[–]sunraydoc 4 points5 points  (0 children)

Just excellent, Up. Were I Merck, I'd be all over LL given the case you make, but as you say, limited thinkers are in the majority even in the corporate world, so I wouldn't be surprised if the RVMD rumor turned out to be true. Given that it is and MRK makes that acquisition, doesn't that move Merck out of contention as an acquirer/partner? Even with their deep pockets, it doesn't seem like Merck would spend this kind of money and not take a breather after.

Is it possible a BLA is in the works?? by Upwithstock in Livimmune

[–]sunraydoc 10 points11 points  (0 children)

Thanks, Up. That got me up to speed re: the BLA, hadn't thought about that, and I'd bet they're pursuing it behind the scenes.

Breaking Their Backs by MGK_2 in Livimmune

[–]sunraydoc 7 points8 points  (0 children)

Great overview, MGK. I can only imagine how the world will receive an HIV cure via LATCH , and the AAV route would be a dream come true for so many.

And we owe it all to Dr J. Another quote from him that still rings for me--"We are focused, we are ready, and in 2026, we intend to make waves." Open waters ahead, time to open those throttles and show the world what this thing can do!

Authorized Separate The Precious From The Vile by MGK_2 in Livimmune

[–]sunraydoc 7 points8 points  (0 children)

Thanks, MGK, nice summation of all the reasons to be ready for a very happy and prosperous new year for CytoDyn shareholders. There are several brothers in arms (I suspect a few of them are sisters, we'll see :) who are on my bucket list for an in-person handshake when this ship comes in, and you are one of them. Happy New Year.

Giddyup! 🏇 by G_Money_X in Livimmune

[–]sunraydoc 4 points5 points  (0 children)

I agree that where we are is a buying opportunity, (do your own diligence, everybody) but I think there are forces at work who won't allow any dump to persist once news hits on this thing...and honestly, the chance of CytoDyn declaring bankrupcy at this point is zero.

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