Looking at Linkedin profiles of the three, two have profile entries indicating they started at Anavex Nov 2023. Dr. Lopez-Talavera doesn't have Anavex in his profile.

Anavex replay from Noble Capital Markets Healthcare Conference - April 18 2024

Anavex calls the AD OLE study Attention-AD, the 2b/3 trial is called 2-73-AD-004, see the Dec 2022 presentation on Anavex website.

Scan costs
Hey Doc, for awareness these are the costs ICER just used in estimating for the recent approvals in Dec 2022:

Monitoring Costs
For the first year while a patient used donanemab or lecanemab, we assumed they were monitored for ARIA using brain magnetic resonance imaging (MRI) every three months. Because evidence suggests the vast majority of ARIA occurs within the first year of treatment, no MRIs were modeled after the first year on treatment. We assumed an average brain MRI cost of $261.10 per scan (HCPCS code 70553).
For donanemab, we modeled a PET scan given every six months while on
the drug to test for complete amyloid clearance. If a patient stopped treatment with donanemab due to achieving complete amyloid clearance, they received a PET scan every year to test amyloid levels if they had not reached moderate AD. We assumed an average amyloid PET scan cost of $4,467.

Adverse Event Costs
In addition to the brain MRIs described above for monitoring, if a patient experienced an ARIA event, the patient received a brain MRI every four weeks until the ARIA was either resolved or stabilized.
The average duration of an ARIA event was 12 weeks; therefore, a patient that
experienced an ARIA event received three additional brain MRIs associated with managing the adverse event. We assumed an average brain MRI cost of $261.10 per scan (HCPCS code 70553).

Only 2-73 for PDD and 3-71 for FTD were on the pipeline presented at JP Morgan on Jan 12 2023.

The Australian Conference has a link from the RSAA FB site.
https://www.facebook.com/rettaustralia

Looks like Rett Syndrome Association of Australia presented at the 2nd Childhood Dementia Symposium in Sydney and Dr Missling presented on the possible usage of Anavex therapeutics for childhood dementia.

10-K scheduled 12/28

There was a UK video a few months back where a Dad stated his adult daughter talked for the first time in many years and a doc in the trial stated he had a trial Retts patient also talk which he had never seen in his 20 years of practice. Both of these occurred after just being titrated to the high dose 50 mg.

Audio replay of Nov 28 earnings call on YouTube

Trial and SAP documents

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

Look at the right top menu go to "supplemental content" select Supplement 1 the Trial Protocol, it has the SAP as part of the document.

URL to Info on Dr Liau presentation Oct 26

https://www.neurosurgery.pitt.edu/news/liau-talk-glioblastma-immunotherapy-treatment

Assuming times are for London the presentation is scheduled for 5:10 am EST Thursday June 23. Will make for an interesting morning.

Would be interesting to see if AVXL can clear the CNS related CV19 longhaul symptoms. Don't see the value in jumping into the initial CV19 disease therapeutic treatment pool given there are decent treatment options coming to market now so starting trials now would not make sense given PD and PDD and FTD are all waiting on getting the next set of trials initiated.

Interim Analysis

- Would be in the protocol if AVXL management felt it would be beneficial, it is a serious and significant decision point in protocol design.

- The trial was quick to enroll and of fairly short duration for a P3 which would weigh in favor of no interim analysis.

- AVXL would be quite limited in the information they could gain if they want to avoid incurring a scoring penalty at the end of the trial.

The following provides a decent insight to the decision process:
http://www.pmlive.com/pharma_intelligence/Assessing_the_value_of_interim_analyses_in_clinical_trials_1325728?SQ_DESIGN_NAME=2&;

URL to Annual Shareholder Meeting and review of trial results

The URL to the call is in the first paragraph of this press release:

https://www.irdirect.net/prviewer/release_only/id/4764726

Looks like Jan 2021


https://in.finance.yahoo.com/news/anavex-life-sciences-receives-michael-120000669.html

Wash Sale
Sell an equity at a loss in a taxable trading account
Buy the same or like equity in your portfolio, any account type both taxable or tax deferred or exempt, within the time period of 30 days before or 30 days after the loss sale.

I have BRPA on a seekingalpha watchlist which surfaces the PR's. Neuro has taken to using BRPA to communicate with the market. It does seem odd as the merger hasn't happened yet. As Neuro is private I would still expect Neuro to release via their own mechanism, however it is not listed there.

https://www.neurorxpharma.com/category/press-releases/

NeuroRX PR was on PR Newswire saw on Seeking Alpha under BRPA

https://seekingalpha.com/symbol/BRPA/press-releases

Communicating Trial Results

I found this guidance valuable in providing perspective for communication strategies. For Cel_Sci the trial results will be material so the timeline for communicating to shareholders will be short once they are confident in the message and the data behind the message.

https://westwicke.com/2019/11/keys-to-successful-disclosure-of-clinical-trial-data-and-milestones/

NIH TESICO trial with Remdesivir

Unfortunate they are using Remdesivir instead of Leronlimab, as that would have paired Aviptadil with a second drug that has been show to be effective on critical Covid patients. Seems too late in the disease progression cycle for Remdesivir to make the difference. Together Avitadil and Leronlimab may have been a winning combo and may also be a winner for Covid Longhaulers.

The URL to the suspended NICE project with NWBO

https://www.nice.org.uk/guidance/indevelopment/gid-ta10143

VB, please speak for yourself YOU don’t want a reverse split, you don’t speak for all shareholders! Do you want to remain on the OTC waiting for the stock price to reach a level necessary for RLFTF to meet the specific listing requirements?

Toucan Capital Corp. follow up note:

Not sure of this has been noted already; To add to the message from Poor Man I see Linda F Powers is also listed as a Co-Founder & Managing Director of Toucan Capital since 2011, which overlapped with the time Kelly Ganjei was there.

Info regarding negotiations status re: sale of ZYESAMI treatment to US DOD

Interesting Info from S4 of Big Rock SPAC and NeuroRX that impacts RLFTF and drug sales from pg 240, URL at the bottom

In April 2020, NeuroRx was invited to enter the Coronawatch Program, a competitive program maintained by the Biomedical Advanced Research and Development Authority (“BARDA”) of the US Department of Health and Human Services. In September 2020, NeuroRx was approached by Operation Warp Speed (“OWS”) and invited to enter into weekly collaborative meetings with OWS’ multifunctional Product Collaboration Team in order to refine plans for formulation, scaleup, packaging, storage, and stability of a potential commercial


240

Table of Contents

presentation of ZYESAMI. In October 2020, NeuroRx was invited to submit a proposal to a Broad Agency Announcement published by the Department of Defense Medical Countermeasures program. In November 2020, following review of the initial proposal, NeuroRx was awarded an Other Transactional Authority procurement by the Department of Defense Medical Countermeasures Program under which the US Government proposes to procure prototype courses of ZYESAMI sufficient to treat 30,000 patients. The OTA further requires that

NeuroRx provide scaleup plans for the potential manufacture of 100,000 treatment doses per calendar quarter commencing in the second quarter of 2021. NeuroRx submitted a final proposal in response to the OTA in December 2020 and has been advised that the procurement is currently under technical review, pending results of the phase 2b/3 clinical trial that will complete its primary endpoint period in late January 2021. Should these data fail show evidence of efficacy in treating Critical COVID-19, NeuroRx believes it likely that DOD will not award funding under the OTA. Should a procurement be funded and should NeuroRx derive profit from the revenues of such procurement, NeuroRx is obligated to share that profit equally with Relief Therapeutics.

https://www.sec.gov/Archives/edgar/data/1719406/000119312521019278/d56937ds4.htm

Trial Results and "hold" vs "sell" your position

A few thoughts on determining next steps:

Are you a trader or an investor here for the largest gain? You can take out a significant percentage of the shares and let the rest ride.

Should the trial be successful the inhaled version has the most revenue potential for RLFTF. Sticking around for that while running trials in EU and working on the BLA submission will take as much patience as the investment in this ride since last spring has taken.

Ask your CYDY question on a CYDY board!

Interview with Dr. Janet Woodcock new acting FDA commissioner

An audio interview of interest to RLFTF investors conducted on November 9, 2020, with the editors of New England Journal of Medicine. They discuss the EUA and Accelerated Approval processes in the scope of COVID therapeutic trials. Interesting discussion regarding the importance of trial sizes, the challenges of treating COVID across the disease stages as well as Dr Woodcocks experience with therapeutics. You can listen to this audio without subscribing to NEJM.

https://www.nejm.org/action/showMediaPlayer?doi=10.1056%2FNEJMdo005917&aid=10.1056%2FNEJMe2033111&area=

Nature Article: Immune cells gone wild are tied to COVID lung damage

The scientists found that the level of anti-annexin A2 antibodies was, on average, higher in the individuals who eventually died of COVID-19 than in those who survived — a difference that was statistically significant. Annexin A2 is abundant in alveolar type II cells. Several studies have indicated that annexin A2 is involved in Ca2+-regulated exocytosis, which signals storage and secretion of lung surfactant. This may provide some background on the effectiveness of the MOA behind Aviptadil.

https://www.nature.com/articles/d41586-020-00502-w

10K Risk Factors Disclosure Section

Buried? It is in the the section of the 10K where risks are disclosed and is appropriately disclosed. They have clearly stated on CC that the NASDAQ has not approved the up-listing so this is no surprise.

Moving shares to a Roth IRA

You can move shares from an IRA to a Roth IRA, or from a 401k to an IRA then to the RothIRA. You may want to check that if these are options you have. There are tax implications to moving pre-tax IRA funds or shares to a Roth IRA.

28 days end Jan 4, wahoo

Why RLFTF? A few thoughts...

1 - They own the license to sell RLF-100 in the core target markets

2 - They are funding the trial

3 - They will fund the nebulizer trial

4 - They will fund trials in EU to expand the market

Updated link to the Great Plains Health video on Aviptadil

https://nebraska.tv/news/local/exclusive-drug-at-great-plains-health-helped-save-local-covid-19-patients-life

RLFTF is not part of the NeuroRX merger and uplisting

Why are you implying RLFTF may be part of this merger? Has that message ever been communicated by RLFTF?

Features of Fast Track Designation

1. Actions to Expedite Development and Review There are opportunities for frequent interactions with the review team for a fast track product. These include meetings with FDA, including pre-IND meetings, end-of-phase 1 meetings, and end-of-phase 2 meetings to discuss study design, extent of safety data required to support approval, dose-response concerns, and use of biomarkers. Other meetings may be scheduled as appropriate (e.g., to discuss accelerated approval, the structure and content of an NDA, and other critical issues). In addition, such a product could be eligible for priority review if supported by clinical data at the time of BLA, NDA, or efficacy supplement submission

2. Submission of Portions of an Application (Rolling Review) If FDA determines, after preliminary evaluation of clinical data submitted by a sponsor, that a fast track product may be effective, the Agency may consider reviewing portions of a marketing application before the sponsor submits the complete application

Source starts on pg 6: https://www.fda.gov/media/86377/download

I have only seen Fast Track Designation benefits from the BLA rolling review in the biologics I have invested in, That said most companies don't disclose details of meeting logistics that are some of the other possible benefits. There is nothing mentioned about EUA specifically however I assume the open communications channel would leave that door open.

I am optimistic that Aviptadil is granted EUA as soon as the trial enrollment is completed. The demand for help treating folks with COVID lung infections is overwhelming at this point.

New shares to be authorized at .01

The .01 share price is the par value the company has set for the shares and has no bearing on what they will actually be sold for when they are issued to the public. There is a lot of info on par value available online if you want to understand why it is applied and the impact is has on taxation of authorized shares in some jurisdictions.

Clarifying the Trial Review Process

The 28 days is the time that must pass after the last person is enrolled before the data is unblinded to NeuroRX for analysis. If the trial is over there would be no reason for the DSMC to review the data like they do in interim analysis.

It will take ~7 days to get trial data uploaded from the trial sites. It is likely to take 7-14 days to have top line results and at least 14 more days for the detailed analysis to be prepared to submit to the FDA.

These are optimistic timelines. For many trials they take several months to compile and report on trial results.

If NeuroRX doesn't obtain Emergency Use Authorization prior to top line results then that may be the first time frame for EUA to be issued. Submission of a biologic license application (BLA) should be the final step necessary for actual "approval" of the biologic license to sell the drug outside of the EUA terms. This should be accelerated as NeuroRX and RLFTF were granted Fast Track Designation by the FDA.

Please Stop Raising Doubt - "Extraordinary General Meeting"

What Is an Extraordinary General Meeting?

An extraordinary general meeting (EGM) is a shareholder meeting called other than a company’s scheduled annual general meeting (AGM).

https://www.investopedia.com/terms/e/egm.asp

The reality is RLFTF has on the near term horizon a significant opportunity to sell significant product into a new market. If that opportunity presents itself they need to have the ability to raise capital to pursue each region our country. The management has to determine how to best raise capital given their situation and the available credit lines. The stock doesn't dilute existing shares until they offer it for sale. They are likely to offer blocks of stock as the SP price rises on the back of the trial work of NeuroRX which Relief has funded. That will give them the cash to pursue authorizations and approvals in countries they have direct marketing control of. As "speculators" looking for the quickest significant SP price rise this should make sense. If they have to wait for cash flow from revenue to fund trials in the EU they will be much later to market.

Dr. Janet Woodcock NEJM interview: CV19 therapeutic trials

An interesting audio interview conducted on November 9, 2020, the editors are joined by Dr. Janet Woodcock of Operation Warp Speed to discuss the pace of discovery in the U.S. response to Covid-19 focused on therapeutic trials. It may help some folks to understand the factors the regulatory bodies consider when approving EUA's. You can listen to this audio without subscribing to NEJM.

https://www.nejm.org/action/showMediaPlayer?doi=10.1056%2FNEJMdo005917&aid=10.1056%2FNEJMe2033111&area=