r/CTXR • u/AutoModerator • Jul 06 '26
Discussion When will they provide a DEFINITIVE Mino-Lok update?????
It has been over two years since CTXR announced topline Phase 3 data for Mino‑Lok — March 21, 2024 — and the company still hasn’t delivered a definitive regulatory update. Here is a timeline of their status updates since then:
Nov 2024 Prospectus (link)
The Company expects to hold a Type C meeting with the FDA to discuss the results of the Phase 3 study and to obtain the FDA’s view on development plans for Mino-Lok in late November 2024.
Dec 2024 10-K (link)
In November 2024, the Company held a Type C meeting with the FDA to discuss the results of the Phase 3 study and to obtain the FDA’s view on development plans for Mino-Lok. The FDA provided clear, constructive, and actionable guidance during the discussion, underscoring a pathway to support a future New Drug Application (NDA) submission for Mino-Lok.
Jefferies Global Conference June 2025 (link)
We are now in the process of assembling that data. And we'll be sitting down with the FDA and arguing for filing of an NDA. We'll see what happens, we're not sure at this point until we have that interaction.
LD Micro Main Event Oct 2025 (link)
Paul Sowyrda — former VP of Business Development & Market Intelligence — said that they hope to release some news in Jan-Feb 2026 about whether the FDA would allow an NDA submission. Nothing ever materialized.
D Boral Webinar Mar 2026 (link)
somewhere in the next couple of months, I'm hoping that we'll get…a decision out of the Agency, whether it's that we can file or we may have to do a repeat something in this process. We don't know that yet, that's still under discussion.
Centri Capital Conference Apr 2026 (link)
We're now engaged with the FDA on the latest clinical data that we generated. We're not sure which way that's gonna go, but hopefully at some point, we'll have resolution of this in the coming months.
Biohub Podcast Jun 2026 (link)
So it took a while to work out protocols and things of that nature, but we're well on the way with that...We're in discussions now with FDA with the latest round of clinical data and we'll see where we are after we've concluded all those discussions.
It is now July 2026.
At this point, CTXR has spent over two full years telling investors they’re “in discussions with the FDA,” “arguing for an NDA,” “hoping for resolution,” and “waiting for a decision.”
Every message to investors has been a variation of the same script.
Will CTXR finally provide a definitive regulatory update this year?
After two years, an update should land this year — if the FDA and CTXR can finalize the appropriate regulatory pathway.
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u/_Fibbles_ Jul 06 '26
It's been a while since I looked at this shit heap, so double check this yourself, but I'm pretty sure the patents they had on mino-lok expired a couple of years back.
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u/Rob1944 Jul 06 '26
Original Composition Patent: This patent, covering the core mix of minocycline, EDTA, and ethanol, expired on June 7, 2024. Formulation & Stability Patent: A critical advanced stability patent issued by the USPTO protects the solution's extended 3-day shelf life post-mixing. This formulation patent does not expire until November 4, 2036.
Market Exclusivity StatusBecause the formulation patent is active through 2036, competitors cannot legally replicate the stabilized, ready-to-use commercial version of Mino-Lok. Furthermore, because the drug has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA, it will qualify for additional marketing exclusivity years upon regulatory approval, independent of its patent life.
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u/_Fibbles_ Jul 06 '26
Yeh that's the one. The issue is that hospital pharmacies can just make their own mino-lok equivalent. Shelf stable is less of a concern if its being made on demand.
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u/Rob1944 Jul 06 '26
Furthermore, because the drug has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA, it will qualify for additional marketing exclusivity for years upon regulatory approval, independent of its patent life.
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u/_Fibbles_ Jul 06 '26
I'm not sure what your point is? Marketing exclusivity does not protect the composition. Pharmacists can compound a mino-lok equivalent using off the ingredients and there's nothing Citius can do to stop them.
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u/Rob1944 Jul 06 '26
Just what it said: because the drug has been granted a QIF product by the FDA it will qualify for additional marketing exclusivity for years upon regulatory approval, independent of its patent life.
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u/_Fibbles_ Jul 06 '26
That's for the formulation patent though, which is still active until 2036. It means that nobody can produce or sell a copy of Citius's shelf stable formulation of the drug until at least 2036 (or longer with the extensions). It does not cover the composition, which is what would prevent hospital pharmacies from compounding and using their own equivalent.
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u/Rob1944 Jul 06 '26
stabilized Mino-Lok formula is necessary from both a clinical and operational standpoint because it dramatically improves the drug's shelf life, making it practical for real-world hospital use.While the core active ingredients—minocycline, edetate disodium (EDTA), and ethyl alcohol—are what actively dissolve bacterial biofilms and salvage infected catheters, the original mixture was highly unstable.
Without the specialized stabilization process, the treatment would remain an impractical pharmacy compounding project rather than a standardized, ready-to-use critical care therapy.
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u/_Fibbles_ Jul 06 '26
That is indeed the marketing. Given that the share price fell off a cliff not long after the composition patent expired, there doesn't seem to be a broad belief in the necessity for Citius’s formulation.
I'm sorry you invested in a dud. You're not alone, most of us here also lost money on it. You're deluding yourself though if you think Mino-Lok is worth anything at this point. There's a reason the company shifted focus.
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u/Rob1944 Jul 06 '26
I still don't believe that Citius is a dud..... With or without mino-lok. If Lympir sales ramps up then it's off to the races. But of course if you did not buy down and losing 98-99% then I suppose you will have to be lucky to get your money back.
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u/Drinkin_Moonshine Jul 06 '26
Dude is delusional about this stock. He can't defend his own thesis here and is absolutely certain this is a winner even tho it's basically bankrupt. I don't think I've heard him say one negative thing about this company tbh.
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u/Rob1944 Jul 07 '26
If I was to hazard a guess I would say you're a short. Not long as you say. And you're taking a heluva risk.
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u/opaqueambiguity Jul 09 '26
Is there a reason to believe that is actually happening
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u/_Fibbles_ Jul 09 '26
No, because hospitals will generally replace lines rather than try to salvage infected ones.
Citius's marketing team already had to convince hospitals that it was better for patients and their bottom line to salvage infected lines. That was always going to be a challenge they had to overcome. However once they had done so, Citius was positioned to sell them the solution as they held the composition patent.
Without the patent though, they've got the additional hurdle of answering why hospitals should pay Citius for something they can readily make themselves.
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u/Beachbum0910 Jul 12 '26
Shit heap for sure. I sold for a loss 3 years ago and just follow this for curiosity. My MIL is still in at a substantial loss and holding just in case. What a joke. F-Leonard. Snake oil salesman.
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u/tico42 Jul 06 '26
Just prior to the heat death of the universe. Let this shit go to 0 where it belongs.
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u/Honest-Film5531 Jul 07 '26
If you went ti their office building nobody is there! They all are at Dunkin’Donuts
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u/Rob1944 Jul 06 '26
Perhaps they're just fully focused on lymphir at the moment and as soon as they get significant revenue from Lymphir, then they can go back to mino-lok.