JB... I am not able to PM on this platform any longer. Please see my PM on another platform. Thanks.

That's a good point, impacting valuation models.

I disagree JT... JB and Bill are on target here. It's the right strategy to go after the hardest patients first... the patients no one else wanted to touch back then (Mar-Aug), and it has propelled us far ahead of the competition as a result. Once the IV is approved for the severe patients, the drug gets rolled out and begins demonstrating efficacy, saving lives, building a reputation, and becoming the go-to-drug for ICUs around the world. When the inhaler (the real breadwinner) steps out into the spotlight, it steals the show. This is a take-all strategy, and I love it.

Play the reverse strategy for moderate, and we get caught up with all the other competition in that market. Its a weak strategy.

Additionally, although the IV is likely also effective on moderately ill, the inhaler is expected to be a more-direct treatment... right into the lungs where covid exists. As Dr. Javitt explained... its a lot harder to get a drug approved through the fda for anything going into the delicate lungs.

My guess is... we get approval for severe, then docs become comfortable with the drug and begin using it on less-severe patients to prevent escalations to ICUs, until the inhaler is approved.

Awesome update! Thanks Tigger!

There are many unanswered questions on these vaccines. Here are just 2 that concern me.

- Vaccines are 95% effective. How does one know if they fall into the 95% or the 5%? Are there follow up tests to determine this?
I will be falling into the 5% category.

-2-5 Vaccines will be available. Who determines which vaccine to use and on who?
I will be determining that.

For me, I'm not taking any of the vaccines. Therefore, it will be 100% ineffective for myself and the many who see right through this crap. 2 very good questions JT.

Uhhhmmm... no. Don't you think you are reading waaaayyyyyy too much into that statement? Don't you think you might be engaging in over-the-top speculation here? I think perhaps you're just making stuff up... right out of thin air.

I agree with Black on this one. Trying to force the FDA isn't the right approach. The drug is working its way through the FDA process... and its likely NOT the FDA holding it up. The holdup could be a large list of other reasons. People complain and bash the FDA, when the FDA is not likely the bottleneck.

On the other hand Black... I disagree with your assessment that investors are signing the petition for selfish, greedy reasons, and here's why:

Many of us have invested in RLF100 since July, Aug, Sept... and since then, we've been expecting the approval for EUA to get done "any day now" and save lives. It's frustrating because we see the daily death stats and hear the stories and worry about our own friends and families as each day passes. We CARE... We WANT to do something about it... this is brewing up to be a "movement".

But doing something shouldn't be attacking the FDA and other government officials. What I am doing instead, is encouraging people to bring awareness to our therapeutic, so the word can get out to patients, families, doctors, hospitals, news organizations, etc.... but let's leave out the stock, stock ticker, FDA, OWS, BARDA and such. Focus on the PATIENT and the MEDICAL RESULTS if you want to do something.

That's what I'm asking investors to do... and I'm asking investors, only because WE all know that this drug can save lives... investors are the ones who currently have the passion to get the word out.

Let's all unite our message with our #AviptadilStopsCovid hashtag. We are using that on all social media posts. Use it everywhere, use it often... create awareness of the cause... create awareness of the hashtag. Forget the petitions, forget the FDA... get the word out to the people who need to hear it! Create awareness. Join the movement.

#AviptadilStopsCovid

FINALLY something we can agree on :D
#AviptadilStopsCovid

Great idea Guy!

Hey guys... some of you may have seen my post on Yahoo yesterday. We are looking to unite all RLFers under 1 hashtag #AviptadilStopsCovid to bring "treatment awareness" to our drug. I understand everyone here is an investor, and therefore, you may be more concerned about the stock than the drug's impact on humanity, but I think its also important to "give back" in each of our own ways. One way to give back is to create awareness of this life-saving drug... patients, families, doctors, hospital admins, and the general public should know it exists. We hope you can help by using the #AviptadilStopsCovid in every social media post you make going forward. Do you part in spreading the word. Thanks in advance!

The vast majority of people will not pro-actively take a vaccine when they are healthy, if there is an effective therapeutic for when they get sick… IF they ever get sick.

Think that through, and know that we are heading towards at-home inhaler treatments.

Excellent point pnnymn

https://ibb.co/rtkBjwY

Check the warrant exercise that occurred in Sept I think. That would explain it.

I'll take any day soon at this point :D

I've been calling Thursday. I think its still Thursday. I agree with your theory, and besides, Ram said its coming "in the next few days"! Looks like exciting days ahead!

Well... if 3m's APR DRGs doesn't produce a NINE-FOLD result, then its TRASH! LOL just kidding. Wow you really helped develop it? Sheesh that's just a little impressive. There may be more to your background than that faceless cloak ;)

Sorry didn't see your post. Rothman score determines likelihood of death, so I would imagine that is an important component of the analysis.

You have to use the Kaplan-Meier statistical analysis method to correctly calculate the advantage of survival.

Reference to the Kaplan-Meier calculation and corresponding inputs occur in 2 separate calculations in the paper...

One for survival...
"Kaplan-Meier analysis demonstrates a 9-fold advantage in probability of survival (Hazard Ratio 0.113; 95% CL 0.037, 0.343)."

And one for recovery...
"A similar 9-fold advantage was seen in cumulative probability of Recovery from Respiratory Failure (Hazard ratio: 0.115; 95% CL: 0.0254, 0.5219)."

Not my area of expertise, but it doesn't look like a mistake to me.

Forget trialsite... we know we're gonna be nine-fold any day now :)
They can catch up later.

My understanding is that the 3-fold was the original pre-print and the 9-fold was the most recent preprint. The difference is in the number of days monitored...

The original preprint (from 8/23) doesn't state the observation timeline, so my guess is it was in the twenty-something-days range.

The new preprint (from 9/5) says the observation occurred at 60 days.

lets not get her in trouble

Not asking anyone in particular... just making sure my understanding is correct, and if so, then pointing out that distinction. Thanks for your confirmation.

I'd like to make a distinction about PR, so that we are all on the same page. Please correct me if/where I am wrong:

PR stands for Press Release (not public relations). In other words, if PR comes out, it is going to come out in the form of an "official" Press Release by either Neuro or Relief on their website and/or through one of the major newswire mechanisms. Then... from that official PR, you will see republishing some of the details of that official PR in news articles, blogs, etc.

If you see a news article that comes out on a day where there isn't any official PR from the company, then it is safe to assume it is opinion or old news being regurgitated from prior PR.

Correct?

Sorry bro... i used to trust you.

The only thing FISHY is that you suddenly decided, after a very long time, to show up on this board, on the same exact day that kmack49 and nyy13 decided to finally show up too.

Should we also be expecting any of these other characters today?

AMG (Mr. Mercedes)
anotherboat12 (aka motorboatmouth12)
dude iligence (aka Dude isill)
Shimanoman
Emptyhead
kalkid1
Wilma Dikfit (aka the complainer)
Vanilla Fitbit (aka Fitbit the Dikfit complainer)

Or should we be keeping an eye open for new accounts?

You're on the wrong board. Go somewhere else.

Hi FitBit... this is Dr. Javvits. I didn't have an account, so I asked Uncle Gee Gee if I could borrow his to respond to you directly. Please see my answers to your questions below.

NEURO AND RELIEF PLEASE READ!!!!
I am soooo glad you put this title in ALL CAPS with exclamations. I almost overlooked it. You are a very very smart guy, and there's nothing we like more than very very smart investors.

ON BEHALF ON YOUR INVESTORS I BELIEVE IT WOULD
BE GREATLY APPRECIATED IF YOU

A) CLEARED UP CONFUSION IS IT 144 or 165
a). IF IT IS 165.. WHY?
Correct... it is 144 or 165


B). Why was the inhaler trial pushed back?
Because we were not ready to start it.
b) Why didn’t you all just keep us updated it was the right thing to do!
We fixed the dates, as they had become outdated, and I was going to send you an email, but I had to meet with the fda, and then I was going to send it to you again, but then BARDA called and that led to me having to setup a meeting with our manufacturers and distributors, and I just finished up with them when I saw this post. I'm so so sorry... I should have at least called you from one of the meetings. I pinky promise next time... ok my little buddy boy? I promise... I really do.

C). What is happening OUTSIDE the US?
c). Israel? Europe? We’ve heard NOTHING on RT side of partnership
As I stated in one of my last videos, we have compassionate use for Israel and working to determine how to service it.
As for Europe, we are not ready to provide updates on that.

D). Why is IV trial pushed back to Dec?
d). Has DMC met? If so did they NOT HALT as even DR J said may happen.
I'mmmm reallllly not supposed to be talking about this yet. I hope that you are ok with that... but if not, just let me know and I will pull everyone together and see if we can make an exception for you. Ok buddy? Just let me know.

We know that you all have decided to do ABSOLUTELY NO “REAL” MEDIA, and while most of us think that is a colossal error in judgement, that decision/mistake is solely yours to make but lack of communication with investors causes confusion/panic, and causes people to
formulate their own “theories” which they then spread fanning the misinformation fire!!
We reached out to all investors, and strangely, there were only 3 who thought it was a colossal error in judgement. Those 3 were you, Dikfit, and STOCK... and you don't have to worry... I don't like those those other 2 whiners... they're babies... and I only like you. I will make you a big pinky promise... once we get EUA approval, we will do some PR. Will that make you feel all better?

PLEASE understand WE are the ones that believe in you with our hard earned money!
Wellll... since you asked PLEASE, I guess so. And also that was something I was having trouble understanding, so thank you for explaining that to me. I really really appreciate it. You are so awesome!

Just be HONEST AND UPFRONT
You know... you have a good point. I am going to quit lying to you all the time and I promise to stop hiding everything from you. That was not nice of me, and a good guy like you deserves much much better. I'm so so sorry.

Well... I'm so glad you posted to this message board. You really know the best way to get your complaints resolved. And I know I'm not the best, but I try really really hard and I hope that we can stay friends.
Please let me know if I can answer anything else for you buddy. I am always happy to respond to anyone who is whining all day every day. You are making a difference! Together we CAN!

Haha... we should invite him over for a poker game... we'll play for shares of stock ;)

And this too...

"The Covid study is moving forward with incredible velocity. We expect to read out the Phase 3 trial by the end of the year. But, ah... 2 weeks from now, there's going to be a meeting of the data safety monitoring board (DSMB). And, they're going to review the first 102 patients in the trial. They have the potential to see both futility, which we hope they won't see. Or perhaps they will see overwhelming evidence of efficacy. Either, which would lead to stopping the trial."

Dr. Javitt
2020-10-15 Solebury Trout Webcast

Hahaha... good DD!

Yes... also... Javitt stated they have more data from the open label studies that is showing similar results. So we should expect the 144 results to mimic the ones below, and I would say this is such a very large difference, that we are expecting to blow the required statistical significance out of the water.

Results

• 45 patients enrolled - had the highest possible risk for mortality
...21 were selected for Aviptadil in June & July
...24 were selected for the control group from May - Aug

• 19 of 21 (90%) Aviptadil patients survived to day 28
...4 of 24 (19%) in the control group

• 4 of 5 (80%) Aviptadil patients on ECMO were removed
...3 of 13 (23%) in the control group

• 15 of 16 (94%) Aviptadil patients on vent were removed
...1 of 11 (9%) in the control group

• 10 Aviptadil patients returned home/care facility
...2 in the control group

• 15 of 21 (71%) Aviptadil patients had 100+ point improvement in oxygenation
...4 of 30 (13%) in the control group

Aviptadil Patient Stats

• 9-Fold advantage of survival P<.001
• 9-Fold advantage of recovery from respiratory failure P<.001
• 8 times more likely to return home or a care facility on Aviptadil
• 3-fold improvement in oxygenation
• 17 of 21 saw improvement in both lungs. The other 2 saw improvement in 1 lung
• 2 Patients developed hypotension - treated
• 4 Patients developed diarrhea - treated

Important Note: At ICU admission, the “Rothman index” and “SOFA score” for Aviptadil-treated patients was significantly worse than for control patients. SOFA measures organ failure and Rothman predicts mortality. That means Aviptadil patients were coincidentally already at a huge disadvantage.

You make a very good point.

You are the PERFECT example of why we don't want PR right now. I have a headache just listening to you butch on this online forum... can't imagine you calling my office every freak'n day.

You want to know what's going on? They're AVOIDING YOU... they don't want you to find out any answers... they're hiding stuff from you because everything is so messed up behind the scenes that they know you would sell if you found out, so they don't want to lose you as an investor so they keep you in the dark. If only you knew the truth, it would be tragic! And... they're hiding it from doctors and the media too... because if they find out about this drug, then they would start asking too many questions, which would lead to the truth that we have nothing and its all a hoax. You're right this is such a mess. We are going to run out of funding. The money we have to last through 2022 is being spent on fat salaries and bonuses and we will be out of money in a matter of months! These guys are sucking us dry right before our eyes. No wonder they aren't answering the phones... and that's why they have a bogus email address too. And you make a good point that Javitt is related to both companies... he's actually financially screwing everyone TWICE!

OR... they are too busy for you because they are working through the fda process and ramping up distribution to eradicate a worldwide pandemic.

It is indeed a sad situation... I think about it every day... most of my family and friends know how deep I am into this drug... its all i talk about... we know people who need it.
Right now, there's an outbreak in my area... in fact, my 2 teenagers are currently quarantined upstairs in their rooms, because they were each exposed to different infected individuals at 2 different schools. They will be tested this weekend. I often think about all the people who have covid right now who are just a few weeks too short of having RLF100 save their lives. I know the urgency... we are all feeling it. But our day is coming soon... very soon... and it will come with the PR we all want to see. And... I think the news will spread through the medical community faster than any other drug in recent history... everyone will know about it, and if we do it right... everyone will have access to it.
Have a good weekend 13ryant... I know you have the best intentions.

13ryant... I hear your point, and we may not agree on this. In fact, I'm sure there are many CEOs who would handle the PR differently. Regardless of approach... I think we all cross the finish line and the patients & medical staff will have a victory.

In the meantime, I will practice more patience... clearly not the way to end the week on a positive note.

Have a good weekend everyone! Let's see what next week holds!

BECAUSE THEY DONT HAVE THE C U R E !!!!!!!!

Look everyone. I understand we are ALL a bunch of impatient investors (myself included). But think about how much DEMAND there will be for a drug that clears out 90% of the ICUs! THE WHOLE WORLD IS GOING TO BE FIGHTING OVER OUR DRUG!!! And if you think people will patiently wait for us to finish getting everything ready to go, then JUST TAKE A LOOK AT HOW FREAK'N IMPATIENT YOU HAVE BEEN! It would be a total disaster to do PR right now! THINK!!! Think outside your price-spiked head. This isn't some car battery we are announcing here!

and stir up more chaos than we are equipped to handle... that could derail our final efforts to ramp up for worldwide distribution... The demand for information and drug availability will simply become overwhelming at a time when we need to be heads-down-focused on delivery. "Hope" is not the right trade off for "delivering". Do you want to get the drug out as quick as possible? Or do you want to delay it and give people hope?

Ok... I went back and read your posts... I apparently have confused you with another poster. My apology. That being said... I know you are a strong advocate for PR and its importance (and so am I), but I disagree that right now is the time for it. I strongly believe that we need to have our ducks in a row before being thrown out to the political and media wolves.

Once we are ready with the 102 patient data, manufacturing, and distribution, we will see at least an eua... and that will be a bombshell moment. Media coverage will come without trying. The drug will have a major impact on ICUs around the country and then the world. Heck... we might even see news about how much news we are getting (jk).

So if you still disagree, I get it. But PR and media coverage right now isn't necessary... actually, i think it would be extremely difficult to proceed with all our necessary preparations when the whole world is begging for the drug.

That appears to be the consensus. Not concerned at all. We are in the process of proceeding as the front-runner covid play and I'm good with the timeline.