FY...Interesting From Zaran....13 hours ago on the Y board.
The confluence of timing and events is rapidly approaching. Disgruntled former and current Dept. of Health and Human Resource employees are enumerating issues we each have learned about through our involvement here and in the public tackling of the Covid-19 pandemic.
On May 26th. the DSMB of the ACTIV 3b Clinical Trial monitoring the results of the Aviptadil vs.
Remdesivir vs. Placebo comparisons is going to meet to review all of the data from those trial participants who have completed 90 days post infusion to date. We are being told that they will also consider all other data available to them, including (my belief) the information / data packages included with the EUA and BTD, most recent filings. If the drug works as we believe, then, these board members will see "again," not only the safety of VIP in this IV version, but it's overwhelming efficacy compared to Remdesivir and placebo. Remembering that the April DSMB meeting was "delayed' so that precisely and specifically MORE data would be available for them to REVIEW! This is an extremely important meeting. As we were lead to believe earlier this year, the preponderance of trial participants for the Aviptadil portion had a higher percentage of patients so all the better for safety and efficacy readings at this critical juncture.
What do they do when they update their knowledge with these possible results? Good question needing to be placed in context to the above mentioned internal ongoing inquiry and to the external Congressional investigations which are becoming increasingly strident in "demanding" working therapeutics and now, preparation for subsequent (think, Fall) Seasons of Covid infections. Funding for the Covid Pandemic War is also concurrently in full swing in Congress. Results are being demanded by both republicans and democrats, and is in no small way a part of this funding process. Yes, even CongressPeople are investigating and becoming dis-satisfied in their analysis of results. Add to this mixture... Preparation of any new therapeutic by a small organization like our own and "now" collaborator NRXP, is as has been said by Dr. Harris in his most recent public conversation with Dr. Fauci, going to take a few months for initial production and dissemination under BARDA's stewartship to reach hospital ICU's across our country. The rest of the world not even considered, yet!
Throw in the fact that our trial is the only one left in ACTIV 3b for critically ill patients. Throw in that the newest EUA granted for Olumiant is only marginally better (2 or 3 percent) than it's comparison to Remdesivir not 4X better like our racehorse Aviptadil. Throw in that more recent studies have found that Remdesivir "does not work" for late stage covid. And, recommendations that it be moved to being an earlier stage therapeutic. Keep everybody happy, right?
Consider that on April 22nd. India issued an EUA for Aviptadil with a report of outstanding results on all measures. Consider that the Swiss Inhaler Trial has ended recruiting and results will be forthcoming as final results are tabulated. Are we the USA, the premier Medical Establishment, or what? Late to the Party?
And, perhaps more important than anything else is that 300 people here in the USA are dying needlessly everyday from respiratory complication of Covid-19. I say that just having gotten over the disease. Fortunately for me, it was mild, but for those who can't breathe, hello? what in god's name are we waiting for?
We've all been waiting and if lucky, we've learned patience and have a better understanding of how our government works and certainly how the medical establishment does it's thing. So, we are wiser and smarter for everything we have gone through. Don't get me wrong, no where did I say easy or fun, it's been hard I'm sure on all of us. But, there comes a time, an event is created by multiple interactions, a black swan event is just this very thing. Seemingly, disparate occurrences happening create. This is a time now when many related areas of importance to us shareholders and believers in this drug that are acting in synchronicity. Is there enough momentum to get us over the hump? If the results of the IV infusions in the ACTIV 3b trial are as anticipated, I think we get our EUA now. Trial stopped, immediate approval.
Why? It's getting awfully hot in Washington with the bickering and CongressPeople aren't stupid. They know about Big Pharma, too, and get compensated by lobbyists and in donations to their PAC's and campaigns. Nothing new here, but a rising tide of trust has been turned into a rising tide of dis-satisfaction and questions of betrayal and selling out. Bottom line, voters are people like you and me. All the things mentioned above.
Don't fail to see that the spring is wound very, very tight. If we were to get an EUA, this stock is going to explode. Market caps are as much extrapolations as data, expect lunacy.
My opinion is reflected in my posts, and it is never advice to buy, sell or trade any securities. Do your own due diligence before purchasing anything in the stock market.
