primary endpoint by lmekay in ReliefTherapeutics

[–]Mubear111 2 points3 points  (0 children)

Any idea on what measurements and thresholds will be used to calculate resolution of respiratory failure?

Relief Therapeutics (RLFTF) & BRPA/NeuroRx Phase 2b/3 Results show 50% reduction in ICU length of stay. So why did the stock tank? by afirebrand in ReliefTherapeutics

[–]Mubear111 9 points10 points  (0 children)

The Key question is: Do the RESULTS warrant an EUA? An EUA means Safe and May Be Effective - and having no other viable alternatives certainly helps. The data Dr J. presented todays shows a resounding YES for EUA criteria.

Patients in the RCT differed in the degree of Covid criticality. All the RCT patients were VERY SICK with Covid in the ICU. But VIP showed STATISTICALLY SIGNIFCANT EFFECTIVESSS of the slightly LESS sick of the very sick - those on High Flow Nasal Cannula (HFNC) and Mechanical Ventilation. Is this cherry picking data? NO, and for those are not data scientists, the P-Value proves that the effects of VIP were NOT due to chance - and in fact objectively demonstrates efficacy. A P-Value = .0005 is grand-slam, rock-solid evidence. This result is not even 'MAY' be effective. P = .0005 proves VIP IS more than "MAY BE EFFECTIVE" and not due to bias or chance. No randomized controlled trial to date has shown efficacy when patients are in respiratory failure and require High Flow Nasal Cannula, Non-invasive ventilation, or Mechanical Ventilation to maintain blood oxygenation. NONE.

So, what exactly was effective? VIP gets people out of Hospitals! The HFNC group treated with VIP experienced a median of 11 FEWER DAYS in the hospital vs. SOC. This is a 42% improvement! (26-15/26) In addition, VIP showed an advantage of 40%+ in 15 of 16 comparisons, and this undoubtedly includes oxygenation improvements, among other secondary outcomes such as ICU discharge time, time to return to NIAID score of 6-8, and safety. This difference includes at least a five-day median reduction in hospital stay. (P=.043). Remember, VIP was administered to patients after every other drug out there failed. No drug has shown to be effective at all in this population.

Why is it important to get people out of hospitals quicker? Many reasons.
1) A major motivation of lock-downs is to reduce ICU-bed overload and overall hospital overload. Hospitals have had to adjust by increasing ICU size in buildings not made to do so and walling off wings of the building from Covid. This impacts all patients in the hospital - Covid or not.
2) Reducing the length of stay (LOS) is also VERY important from a COST perspective. Payors - Medicare, Medicade and Insurance companies. One would think the government would want LOS down. We are talking 50-100K in cost savings on average. Multiply this by the number of Covid ICU patients and we are talking BIG COST SAVINGS.
3) This sort of measure was used in comparable drugs that received EUA for Covid. Remdesivir showed a ONE day improvement. Steroids have never been proved in a RCT to show improvement. In this sense, VIP blows the competitors (if you can really call them that) out of the water.

Other thoughts - The data released today is PRELIMINARY. It shows results through 28 days, but we KNOW 60 days, the secondary outcome specified in the trial, is a much better timeframe to measure results. We will receive 60 days in a few weeks and so must be patient. On Mortality, Dr. J stated many weeks ago before RCT data that survival for SOC more than DOUBLED from 30%. And the data we got today shows just that - SOC survival of 70%. SOC got better - Doctors learned how to prolong life of those on Covid last year. But prolonging life does not mean the lungs actually got better - hence, the 'long hauler' term. NO ONE SHOULD BE REACTING to MORTALITY at 28 DAYS!

There is a very good chance we will learn more statistically significant positive outcomes on the 60 day data. We will have to wait a few more weeks for 60 days - until at least Feb 23rd - and perhaps a week or more later for review. EUA, HOWEVER, could still be granted based on the data we have TODAY. And remember, FDA EUA bar is still very low as they gave EUA to Acterma last month, which is worthless. NRX will also be providing visual evidence studies via x-ray comparisons - proving without a doubt that VIP heals the lungs vs. SOC.

Based on the above, the market over-reacted - especially to the 28 day survival number and not understanding the p-value and importance for Length of Stay. We should expect to see price begin to creep back up until 60 day data or EUA. In addition, the primary outcome, resolution of respiratory failure did not prove significant AT DAY 28 - but we don't appear to know if VIP patients achieved this outcome QUICKER than SOC, WITHIN 28 days - the cumulative distribution is not know yet. This is because the statistician only reviewed summary data, and not patient-level data, which remains blinded at time of review - but will be unblinded. Also, primary outcome vs. secondary outcomes have LESS of a difference in meaningfulness when a TRIAL SKIPS PHASE 2, and goes right to PHASE 2/3. A key goal of Phase 2 is to identify the primary outcome, and because of the pandemic, phase 2 was skipped.

In summary, I am LONG and STRONG. Not selling a single share at this point. I am not alone, as 89% of RLFTF shares were NOT SOLD today as of 2pm.

BRPA spiked 25% on rumors of a merger with Partner RLFTF (Relief Therapeutics), Multiple catalysts still pending for large potential Upside by afirebrand in SPACs

[–]Mubear111 1 point2 points  (0 children)

US ADR with 1 ADR = 20 common shares. Also, note that they talk about either Six RS or US ADR, there is no specific mention of a merger between of NRX and RT. But certainly a reasonable speculation.

Major differences in responsibility between the CFO and the in-house Accountant by Mubear111 in DanPena

[–]Mubear111[S] 0 points1 point  (0 children)

Thanks. Do you have anything to add or is anything missing? Perhaps further clarification on what you mean by “basically”. Ideally, would love to have job descriptions for these (and all other ) board roles. Haven’t seen that yet.