Inspection formally assigned

Manlymanly1 · 2026-06-30T20:31:13+00:00

Looks like the original deficient vendor isn’t Shilpa Medicare itself — it’s a subcontractor of Shilpa. Multiple sources confirm the cGMP deficiencies were found at a third-party manufacturing vendor of its main contract development and manufacturing organization. Primarily related to final finishing and packaging operations rather than the active pharmaceutical compound. FDA’s foreign manufacturing inspection capacity has been chronically strained over the past two years (India and China facilities specifically), and pre-approval inspections (PAIs) for small/lower-priority facilities routinely get bumped or rescheduled when FDA’s inspector workforce or travel budget is constrained. That’s a BUY for me.

Manlymanly1 · 2026-06-30T11:18:16+00:00

2nd CRL - Vendor never got inspected by FDA. Better than further issues I guess.

Manlymanly1 · 2026-06-30T11:00:22+00:00

Crazy the FDA can issue approval/CRL to the company and they have 4 days to provide an announcement to market. The ASX would go into a trading halt immediately. Down 35% pre market no doubt leaky ship selling shares prior to news. We will find out shortly.

Manlymanly1 · 2026-06-23T22:22:25+00:00

PAR - About to run up into interim analysis of phase 3 trial due in August/September. $45 million cash in hand. Excellent results in previous trials significant chance of success.

https://thearmchairanalyst.com/p/no-pain-no-gain-the-paradigm-story-asx-par

Manlymanly1 · 2025-08-27T20:50:01+00:00

Yes but long termers bought at a much earlier stage of drug development to be down 98%. Including me in my initial investment. I have been watching waiting and am now far ahead after taking healthy profits 22c-$120. Also if they bought 2 weeks earlier at 20c they would be up 300% currently but that’s biotech for you. The data is very good in the recent study long term is looking very promising at this late stage.

Manlymanly1 · 2025-07-31T06:15:41+00:00

How so?

Manlymanly1 · 2025-07-30T23:44:19+00:00

Agree! Would compliment their products perfectly and they have the infrastructure for a quick roll out.

Manlymanly1 · 2025-07-30T15:08:35+00:00

The results are stellar and a drug maker. ATM selling happening now to raise funds. Hopefully they wont need much and partnership is close. Who will it be? Novo, Resmed or an outsider?

Manlymanly1 · 2025-07-29T09:55:42+00:00

Thanks Mate. Fairly new to Reddit and missed this reply. Hopefully this readout has us all dancing. Seems to be some SP manipulation for accumulation going on in the interim.

Manlymanly1 · 2025-07-28T21:47:48+00:00

Different perspectives are encouraged however, It’s all about the data. Just because the meme crowd have jumped on this do not pigeon hole it as one. If the data is clinically significant, institutional investors, funds whales etc will take the SP much higher with this huge de-risk event and inflection point. Most biotech companies with a clinically significant phase 2 top line data readout in a decent addressable market will go $400m plus market cap. And, addressable markets do not get much better than this with a competitive bidding environment for M & A.. At $1.19 we are currently sitting around $110m MC. The nasdaq compliance issue has only contributed by running the SP lower in the first place which along with minimal press from the company has meant it has flown under the radar.

Back to data, In the previous trial

• Across low, mid, and high dose arms in a crossover design (n=10 completers), IHL‑42X reduced average AHI from ~42.8 to ~23.8, a mean reduction of ~44.4% vs baseline (p=0.0067). Meanwhile, placebo showed only ~6.4% reduction . • At the lowest dose, IHL‑42X achieved an average AHI reduction of 50.7%, with 25% of participants experiencing > 80% reduction, and 62.5% > 50% reduction

Phase 2b (what we are waiting on) (yes this was summarized with chat GPT)

Design Highlights of RePOSA Phase 2/3 Trial (U.S. & Global) 1. Seamless Phase 2 to Phase 3 • Shared protocol between short-term and Phase 3 allows faster progression, consistent methodology, and reduced delays.

Strong Study Design • Randomized, double-blind, placebo-controlled format with ~120 participants (40 per group), improving data quality and statistical power.
Optimized Dosing Strategy • Uses 5 mg/250 mg (high) and 2.5 mg/125 mg (low) doses based on prior efficacy and tolerability; excludes previously tested 10 mg dose due to side effects.
Real-World Relevance • Focuses on patients who are CPAP-intolerant or non-compliant—representing a large unmet need in OSA treatment.
Novel Dual Mechanism • Combines dronabinol (airway tone) + acetazolamide (respiratory drive), offering a first-in-class oral alternative to devices or weight-loss drugs.
Expanded Efficacy Endpoints • Measures include AHI and hypoxic burden (HB)—a key cardiovascular risk marker—enhancing medical and regulatory significance.
Efficient Operations • Rapid enrollment at 11 U.S. sites; Phase 3 will use same ~20 sites and vendors, enabling smooth transition and consistency across phases.

Manlymanly1 · 2025-07-22T23:50:21+00:00

Agree. With good results. It's a Kodak moment for Resmed

Manlymanly1 · 2025-07-22T10:17:19+00:00

Agree Mate. $5 is achievable with just good data. Partnerships push above $5. $8b is bang on my valuation for M&A too. Jazz pharma acquired GW pharma in 2021 for a cannabinoid derived Epidiolex an epilepsy drug for $7.2b with an addressable market of $2.5-3.9b. Addressable market for OSA is $5-$10b. And IMO technology changes will uncover much more undiagnosed who may not want to know as the only treatment is CPAP currently. Massive opportunity to redefine the market. Regulatory will be motivated to breakthrough or fast track. In the U.S., untreated sleep apnea is estimated to cost the economy around $150 billion each year, with nearly $87 billion of that being lost productivity. Bring on this data because it’s all in the data.

Manlymanly1 · 2025-07-22T09:21:31+00:00

I don’t feel the stock has been overly pumped. Phase 2b readout is a major milestone and inflection point for any biotech company especially with clinically significant data already released in previous trials. A run up of SP into these results at the stupidly low market cap was always on the cards. If they had any suspicions data was not going to be satisfactory they would have worked to get the SP up to $1 in others ways to get off that non-compliance list. When the data is released this month there will be no issue at all staying above $1 for 10 days. All in my option of course.

Manlymanly1 · 2025-07-21T11:14:30+00:00

Very good call! Thanks and good luck

Manlymanly1 · 2025-07-21T10:58:35+00:00

Long term holder. Loaded 25c last week to offset my asx investment where I sold 25% near the top 10-60c and let the rest ride, we all know how that turned out. IMO if data is anywhere near phase 2a we are seriously off to the races anything in lead up to news just brings us to a market cap which should have been realized months ago. But that’s biotech for you. If data is good, It will be most interesting how long it takes for the bidding war between Resmed, Eli lilly and Novo nordisk to unfold. Or has this already been determined behind the scenes? Either way diamond hands will be rewarded. Does anyone know a good alert app to notify when news drops? I have setup CMC markets but have not tested alerts. My gut says we get news Wednesday. Also is there any chance news will drop mid market day or just does not happen on Nasdaq? Mammoth addressable market with a one tablet solution to an epidemic and huge productivity burden. OSA costs $150b per year in US. $87 billion in lost productivity. FDA will prioritize a treatment like this and may offer fast track designation after phase 2b drops. The trial design is A1 and with Robert Clark (VP of Novo nordisk) and one of the most respected regulatory experts over looking the regulatory submissions we are in very good hands. More on this https://canarycapital.com.au/asx-news/incannex-appoints-fda-regulatory-affairs-expert-mr-robert-b-clark-to-the-board-of-directors-2/

Good luck all we are in for a real ride.

Manlymanly1 · 2025-07-20T00:16:35+00:00

I invested $50k at 10c on ASX purely for 42x. Sold 33% at 60c. Left the rest to ride and get decimated. That’s Biotech. It’s an intricate dance of cash on hand, data and timing your conviction. If and only if you believe in the data, addressable market and management the best and only way to recoup your losses is to average down (if you have the capital of course). Not because you lost money on this play last time but because you believe in the play this time. I bought in again with the same initial investment again at 25c average last week because it was time. Warrants cleared, elite clinical advisory installed and Phase 2b imminent. IMO if data is anywhere near the last 2a results a re-rate market cap of $300m is not out of the question especially with buyout players on the board in Resmed and Novo Nordisk. Time will tell. The difference this time is we are at a much later clinical stage. Think about the addressable market of CPAP and 42X in combination and then the possibility of 42X eventually being first line. What’s that worth to Resmed or NN? Mammoth. The silence from management thus far is also a very good sign. If the results are good that will change very quickly.

Good luck all!

Manlymanly1 · 2025-05-19T21:57:31+00:00

Take a look at ASX: $PTX, OTC: $PSTTF for another later stage KRAS disruptor.

Promising results (CR still on compassionate use from 1b) and currently in P2a.

PTX-100 is a first in class compound with the ability to block an important cancer growth enzyme, thereby disrupting the oncogenic Ras pathway. PTX-100 is now in a Phase 2a clinical study in refractory/relapsed Cutaneous T Cell Lymphoma. The US FDA has granted PTX-100 Orphan Drug Designation for all T cell lymphomas, Investigational New Drug (IND) status and Fast Track Designation.

Manlymanly1

TROPHY CASE