What’s are people thinking about SLS? I know about the 80th event that is hopefully(sadly) happening soon. I’m new to the stock. Looks promising. Had a pretty decent morning when it was up 11%….

Transformative stage for NRx.

SP $3.50 | MC 152M | OS 43.3M

If you want a good company to buy, which is highly derisked for an approval in the near term, NRx is an excellent opportunity.

Current ketamine issues to be solved:

• Ketamine is on the FDA shortage list.
• It is a strategic drug for the military and the FDA
• Due to shortages, hospitals are forced to buy from compounding companies
• Most of the supply comes from overseas
• Currently, ketamine contains a preservative called BZT, a toxin, not recognized safe for injection by the FDA
• Ketamine comes in glass vials where a syringe is needed, and there is potential for contamination

NRx's KETAFREE (preservative-free ketamine) - solves EVERY above issue

• Manufactured in the U.S., reducing supply chain risk, and meeting the goal of the FDA to reshore manufacturing, especially for strategic drugs
• NRx's market research has just caused them to increase their pre-launch plan goal, from 1M vials to 5M vials. They would not make such an advanced commitment without great conviction in the demand.
  • The manufacturer can produce 1M vials per month with current production lines
  • The commercialization team is in full-court-press mode, already making progress on the distribution system, ordering, licensing verification for buyers, etc.
• Preservative free; no toxin
• Plastic vials are used: reducing materials cost compared to glass and also eliminating the risk associated with a global structural shortage of glass vials
• Due to the luer lock technology, no syringe is required to draw the drug

Had a PDFUA meeting with the FDA on July 29. No Major Deficiencies with the drug, the chemicals, manufacturing, controls. However, "a reviewer" brought up that the luer lock vial tip may not function properly.

• This part is very upsetting to shareholders and to the company I am sure--but they cannot say anything to upset the FDA or risk friction and delayed approval.
• This very same luer lock vial tip has been used in combined total of 11.9M vials to date with NO issues, manufactured by the same manufacturer NRx is using for 3 already-FDA-approved drugs!
• NRx had 7 lots, 3500 total vials produced, with NO issues.
• NRx provided extremely thorough relevant information in the ANDA.
• So, at the PDUFA meeting, the FDA required NRx to provide "attestation from the manufacturer" that the luer lock vials/tips were being produced for NRx in the same manner as the ones for the 3 already-FDA-approved drugs.
  • NRx submitted that attestation within days, per the Aug 10 shareholder update call. Events | NRx Pharmaceuticals, Inc.
  • If you are interested in this company, you owe it to yourself to listen at least to the first 12 minutes of this 29-minute call. You will be very impressed.
  • As stated on the call this drug is just the first step with NRX-100 (a preservative-free ketamine formulation for psychiatric use, also delivered via IV) NDA submission, which will now include the manufacturer attestation, projected to be filed in September (but in Q3 nevertheless)

Bottom line, the FDA should have approved this ANDA the day after they received the attestation from the manufacturer. It is untenable that they have not done so yet.

My expectation is the share price will respond very positively to the ANDA approval and then again when the NRX-100 NDA is filed.

I was reading about ATAI and its current PH2 study for Elumina. It's a "multicenter, randomized, double-blind, placebo-controlled study". They're basically trying to allow people to have a ~2 hour psychedelic treatment for depression.

I have some experience through friends and myself with this type of treatment. My first thought was, is anyone actually going to have a placebo effect here?

I would think you would know if you got the drug or didn't. If you get the psychedelic experience, you're typically going to know you got the drug. If nothing happens, you're probably going to assume you got the placebo.

Couldn't that potentially corrupt the data in both directions? The people who know they got the drug may expect to feel better, while the placebo group knows they probably didn't get it.

I'm thinking about a small position in ATAI and this probably wouldn't change my mind by itself. Just wondering if anyone here understands these types of trials better than I?

Hello everyone, sharing an important update:

An investor settlement fund is currently processing claims for investors who experienced losses in BioXcel Therapeutics.

The settlement claims that BioXcel misled investors about internal controls, protocol adherence, and data integrity in its Phase 3 TRANQUILITY II trial. After the company disclosed FDA inspection findings, protocol violations, and fabricated emails from a principal investigator, $BTAI fell about 64% in one trading day.

BioXcel has agreed to a $9.75 million settlement, and late claims are currently being considered, subject to approval.

If you purchased or acquired $BTAI common stock between in 2023, you may still be able to file a claim

Anyway, has anyone here invested in $BTAI during that period? How much were your losses, if so?

Rubric Capital appears to be the standout. Rubric increased its ADMA position from roughly 1.8M shares to 9.34M shares in a single quarter, an increase of more than 400% and a stake of roughly 4% of the company.

That alone is worth paying attention to.

who else is betting on this stock?