Maybe you are being rash. To function at all in a pandemic for a state agency that is used to working at snail pace is quite an achievement overall. Also what we perceive as personal insults or conspiracy is mostly inability t perform and/or being undermanned since Trump thinned out public servants in all key agencies so many can hardly perform anymore....
But here is a real glimmer of hope at the end of the tunnel:
I usually do not insult myself by going to the Yahoo board but as it is a cloudy Sunday morning and nobody seems to be here I gave it a try as it seems to have more international posters in various time zones and found this amazing write up today by one OU3:
OU36 hours ago
The day has finally come when we have a glimpse of the hyped CD12 RCT readout by CYDY. The results are mixed at best and the bar is set low enough that Zyesami (Aviptadil) can jump over it as the most effective treatment for severe and critical CV19. While the full data reveal is not out for either company, the highlights from CYDY’s Friday press release indicate that at best, CYDY improved outcomes for what appears to apply to a subset of patients. The press release indicates leronlimab improved release from the hospital by 6 days for critical patients. Re reading the release many times this morning, it appears they sugar coated the facts and leronlimab only had an effect for a subset of 62 of the 384 patients. Unsurprising maneuver given CYDY’s management history. Regardless, the remaining results are observational and do not reveal any effect beyond chance. Further studies will be needed to confirm if any of the observational data can prove out to the FDA. It appears from the release CYDY is now scrambling to make that happen with EIND data. Good luck convincing the FDA with non RCT results. A new study will be required and with it they will need additional funding.
As for Zyesami, this week will be crucial, as the pressure is on to see the 60 day results, but interestingly it’s not their only shot to be discovered. The iSpy inhaled study is still in the works and given that Covid is not going away anytime soon according to nearly all the knowledgeable medical advice, I like Zyesami’s chances!
While CYDY may be left for dead trying to fund future trials with an inept executive team and shady financier who is now under serious SEC investigations, Zyesami’s inclusion in the iSpy trial by NIH and plenty of cash by the mothership Relief means Zyesami is very much still in the game.
The most promising fact is that the preliminary results released two weeks ago on Zyesami indicated a medical effect of the drug after 28 days on a subset of HFNC patients. However, there is more to be revealed for Zyesami IV. In fact, my prediction is that Javitt will reveal moderately significant results at 60 days. Why? Because there is a slow down in the progression of the disease due to SOC and this fact masks the results at 28 days. However, my hunch is that after 60 days the differences will be revealed. Add in the the radiographic data (CT Scans) of the lungs, and we will have the ability at the very least to excite the FDA and investors.
The fact remains that this is the first trial ever undertaken with this drug to address CV19 and admittedly Javitt underdosed patients with Zyesami, but Javitt was smart enough to make sure our endpoints were reset and there is enough scientific data included in the trial to detect a “medical signal” (using his words). CYDY did the opposite by not resetting endpoints and firing Dr. Bruce Patterson at IncellDx which excluded his brilliant cellular marker data which would have helped CYDY’s case of detecting a “medical signal” due to the drug. Investors in Zyesami already see signs of this benefit in the EIND results with the compelling lung scan data. While not a primary endpoint for the study, the FDA cares about these medically relevant facts and its unfortunate for CYDY investors that they accepted Nader Pourhassen’s lies to cover up why they kicked Bruce off the team and hurt shareholders!
Lastly, the impact of this drug on Long Haulers (SARS-CoV-2 - PASC) pulmonary issues is the holy grail few are realizing. A vast percentage of long haulers are suffering longterm lung damage and this MAY BE THE ONLY TREATMENT on planet earth that can help them in the FDA pipeline.
? Leronlimab - no
? Other MABs - no
? Arthritis drugs - no
? Synairgen - no,
? EXO-CD24 - no,
? Zyesami - Yes it’s possibly effective for post infection pulmonary recovery.
To recap. I’m disappointed in Leronlimab. It failed it’s primary endpoint which was mortality. If it met it, the press release would have screamed it... it did not. Furthermore, it failed every other secondary unless one subgroup was broken out (62 critical patient in the CYDY study), however this population size is not large enough to convince the FDA regardless of significance.
Zyesami was in a similar boat 2 weeks ago but they have another shot with the upcoming 60 day analysis and the incredible good fortune that FDA changed the requirements for all drug companies targeting CV19.
Add in that NeuroRx has direct ties to Lavin the leading FDA consultant in this industry with direct personal ties to former FDA commissioner David Bessler- now on Biden CV Taskforce, be assured Zyesami is very much still in the game and CYDY is on the outside far behind these connected companies... yet it’s share price puts it at 4x the Market Cap of RLFTF...
I like my chances with RLFTF and BRPAW, BRPR, BRPA family of investments.
Go #RLFTF #BRPA
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