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I know u know this, but just to reiterate for others... I can't imagine getting denied for EUA. The request is for the same exact patients (sickest of the sick) that we've already been approved for with the EAP, and... the criteria for being approved for EUA are 1) the drug must be safe and 2) the drug should demonstrate that it "may be effective". It doesn't even have to prove that its effective... just that it "may" be effective. And of course, we've already proven the safety aspect. It should be a slam dunk.
Even better with the president pushing urgency.
lol... so magical :)
That was nice of you :)
Here is a link to Remdesivir's recently revised EUA on Oct 1... thought it might be a good document to provide some insight to the FDA's thinking. Might also be good for future comparison purposes.
Note what it says about Remdesivir (aka Veklury)...
"Based on the totality of scientific evidence available to FDA, it is reasonable to believe that Veklury may be effective in treating COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of Veklury when used to treat COVID-19 outweigh the known and potential risks of such products".
"There is no adequate, approved, and available alternative to the emergency use of Veklury for the treatment of COVID-19."
The link:
https://www.fda.gov/media/137564/download
Now that would be a worthy beer spill lol
Thanks again for this very urgent warning kmack... we don't know what we would do without you!
A few things in that article that jump out at me about Eli Lilly's drug...
1) You are correct... they need the 2-drug cocktail for better results:
"It expects to submit a request for emergency use authorization for the combination therapy next month, after patients are enrolled in clinical trials and supply has been manufactured."
2) Doesn't sound too convincing: "Lilly had previously released results for a similar treatment using one antibody, which experts viewed as promising. But the new results, of a combination of two antibodies, appear, based on limited data provided in a press release, to be more robust."
3) How quick and effective is it? "The patients in the study were sick with Covid-19, but had not been admitted to the hospital. Eli Lilly said that in a preliminary analysis the antibody combination reduced the amount of virus in nasal swabs of patients after 11 days."
4) Hmmm... "Key data, including the actual viral loads of patients and the makeup of the study population, were not included in the press release."
5) It does have promise, but only BOTH drugs... "The difference in viral load was statistically significant at day 11, unlike some doses of Lilly’s single-antibody cocktail."
6) It did reduce hospital visits, but... "That difference, however, was just barely statistically significant."
Yeah... so all the little truths are coming to light. Thank you for researching that... great contribution.
I honestly think it is by choice to not PR pump the drug/company/stock... the timing isn't right. They certainly have the ability to do major outlets... they've done it in the past... we've been picked up on Bloomberg and other major wires, as well as had interviews on Fox w Cavuto... so it seems deliberate to me. Javitt knows the political game VERY well and is likely more aware than most of the harsh media attacks that can materialize when all the facts aren't ready. Just my opinion, but that's where I'm leaning.
You're welcome
Ok... thank you for the baseless warning.
Thanks for the warnings, but you obviously haven't been following along closely enough. Please don't bring in the typical OS and RS fearmongering... it really doesn't fit here, and we don't want our board polluted with nonsense. However, if you have substance, we welcome your contribution. Thanks for your kind consideration.
I don't disagree. Either they don't have the capacity/expertise for PR, or they are wisely postponing PR until everything is in order. Also note that the new CFO will be "increasing dialogue with the investment community in order to raise awareness and understanding of Relief".
I agree... they may have already been planning to announcement his appointment, but they certainly stuck a few extra items in there to send some positive vibes our way. I wouldn't doubt the CFO himself played a major role in crafting this announcement and all it's little Easter eggs.
A few thoughts…
Last night, Trump “endorsed” 2 drugs in the therapeutics arena. Trump didn’t actually “approve” their EUAs, but rather was implying that he “approves of” their EUAs. He was saying… based on his personal experience with the drugs, he supports the submittal of the EUAs to the FDA. The FDA is the agency that actually does the approval.
So now… Eli and Regeneron are in the “EUA-Queue” with us. And the good news is… Trump will push for therapeutic EUAs to be approved ASAP!
What??? You didn’t expect to have any competition??? That’s ok…
Just don’t forget who we are:
• We own the patent to RLF100 and the process for synthesizing it.
• We demonstrate the best results out of all covid drugs I’ve seen.
• We block the virus from attaching to host cells in the lungs, AND… we prevent the cytokine storm AND... reduce inflammation!
• We are already determined safe by the FDA.
• Our intravenous RLF100 was submitted for EUA on 9/17 – awaiting FDA approval.
• Our RLF100 clinical trials have reached the interim 102 patients on 9/30 – awaiting results.
• Our clinical trial for the RLF100 treatment inhaler has been designed, submitted, and is expected to finish this year.
• Our clinical trial for the RLF100 PREVENTATIVE inhaler has been designed, submitted, and is expected to finish next year.
• We show promise for other lung applications beyond Covid, which also need to be studied and tested separately.
• We signed a Cooperative Agreement with NIH’s Institute of Arthritis and Infectious Diseases to test RLF-100 against the flu virus and other viruses that attack the lungs.
• We signed a contract with Bachem Americas to manufacture drug substance for 1 million patients.
• We signed a contract with Nephron Pharma to manufacture enough RLF100 for 1 million patients.
• We signed a contract with the largest supplier of inhaled sterile drugs in the United States to supply RLF-100 to any US hospital overnight.
• We obtained Companionate Care Protocol in Israel and we’re in the process of determining how to service it.
• NeuroRX’s CEO Dr. Javitt is ranked among the top 1% of quoted scientists worldwide, has successfully taken 7 drugs through the FDA process, and has served in key leadership roles under presidents Clinton, Bush Jr, Bush Sr, and Reagan.
• NeuroRX’s Chief of Operations, Robert Bestoff spent his career at Lilly & Pfizer. At Pfizer, he was head of the entire neuro science and pain division, responsible for $10B of their drugs.
• NeuroRX’s Manufacturing Coordinator, Rich Siegel, is the former head of Johnson & Johnson’s drug portfolio.
• Relief just appointed industry veteran Jack Weinstein as CFO, AND retained previous CFO Jeremy Meinen as Principle Finance and Accounting Officer.
• Doctor (and Congressman) Andy Harris is 1 of 3 experts on the Data Monitoring Committee.
Our team is top-notch. Our team is focused. We're making steady, precision progress. When it’s “go time”… the world will know!
(These are my opinions. I am not a professional. I take risky positions. Please do your own due diligence and evaluation, and seek professional guidance before trading or investing.)
Mike Irwin on Twitter shares these academic papers on VIP, demonstrating applications beyond covid.
https://www.survivingmold.com/Publications/VIP_AN_GALLEY_PROOF_3_20_2017.PDF
https://m.scirp.org/papers/28586
You make a good point here...
"Kinda struck me as odd that the compassionate group data stopped at 21 and there hasn’t been any more prints on the additional enrolled patients."
And btw... glad to see you are making thoughtful contributions again.
PC... thank you for digging up these details. Its good to see the timeline and rate of news spread.
Awesome! Thanks! And... I sent an email to Jason (editor) thanking him for the transparent updates.
jason@endpointsnews.com
Correct, and here's the official publication...
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3665228
Awesome post... seems like there's hope... we're pull'n for ya!
Don't hesitate to bring them in ;)
Sorry to hear about your mother. I do believe there is a longer-term play here. Let's see what comes out of the NIH's side efforts for other treatment applications! Maybe we hear something early next year. Super exciting :)
There is good evidence it could potentially do this for people with lung issues... that would be fantastic! Hope we are having a real conversation about this in the near future... I would love to be throwing around some virtual high-fives with you!
The EUA submission is strictly for the IV form to be used on critical patients only (per Javitt), and although we should have enough data, there is technically a small chance they could ask for more... but you are correct... we definitely meet the "safe" requirement (because the FDA has already determined we are safe when we did our initial interim review at 30 patients), and I would imagine we have enough data to meet the "MAY be effective" requirement with that same data (19 out of 21 critical patients survived).
That being said, we could get EUA any day now; although Javitt cautioned it could take 30 to 60 days.
So... it looks like Javitt and team are working backwards... from most critical to least critical, and we could therefore imagine a SUCCESSFUL timeline to look like this...
1) Obtain EUA for IV to treat critical patients
2) Assess results from the 102 interim review - these results could be used to support the EUA request if more data is needed. It could also clearly demonstrate strong efficacy, resulting in a full fda approval (for the IV form only). It should at least demonstrate enough efficacy to continue trials.
3) Full FDA approval is granted for the IV version only, based on either the 102 interim or the 144 final trial results.
4) EUA and/or full FDA approval is granted for inhaler treatment for mild to moderate inhaler form.
5) EUA and/or full FDA approval is granted for preventative use of the inhaler for the general public.
Each step along the way, opens up our drug to larger and larger populations as the drug continues to prove itself. And hopefully... we obtain SOC status for each along the way!
Not sure if your GILD timeline is correct, but you are correct about the data... the EUA is not dependent upon trial results, unless the FDA wants to see more data before issuing the EUA... as of right now, we should have enough data... but when we get an FDA response, it could certainly be a request for more data.
Correct. Remdesivir and Convalescent Plasma are the only two so far. We will be #3, and we will blow the socks off the other two.
And if it happens while Trump is sick (whether he gets RLF100 or not)... we will get an enormous amount of press, as all eyes are on therapeutics atm.
Simply put:
1) Because we aren't ready yet
2) Because we don't need to
The time will come and it will come effortlessly if the drug has the goods.
You can stop shouting now.
PS... you are the last person we would want on our media team.
White House physician speaking at 11am EST (in 25min)
Agreed... seems staged.
Thank you. Highly speculative. Also highly likely someone is deliberately trying to pump the share price with a fake story. Thank you for digging this up. Much appreciated.
It might sound more like this (use your Trump voice)... "over the weekend, I was cured by a very powerful vaccine, or therapeutic as some may call it, a very powerful therapeutic... you know the word... therapeutic. This drug will save many many Americans. It will save many Americans from the chinavirus, to the likes of which you've never seen."
Can you please provide a summary of what it said? I cant find anything on it. I realize it is speculation, but would like to know what it was about please.
You're welcome... please share it in proper places, so we can strengthen the new investors' confidence. Thanks!
Agreed for sure!
Unfortunately, I don't think DT getting infected is going to impact our share price, unless he mentions the drug by name.
Good morning! Hoping everyone can help with this DD from last night...
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