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You said:
"'Millstone how about providing info that supports your statement of:
Interest in our companion company with 50% of the U.S. rights to RLF-100 is picking up quite a bit."
1. Interest in our companion company...is picking up quite a bit: BRPA, the SPAC that NeuroRx is merging into, is up 42% as of now at $21.68.
2. Our companion company with 50% of the U.S. rights to RLF-100: NeuroRx has a deal with Relief for 50% of the revenues from the sale of RLF-100 in the U.S.
Not sure which info. you were questioning, so here are two possible answers.
Interest in our companion company with 50% of the U.S. rights to RLF-100 is picking up quite a bit. While it hasn't completely been reflected in RLFTF's stock price, I'm confident that it will soon.
After all, RLFTF has the other 50% of the U.S. market and there is an 80/20 split favoring Relief in the rest of the world. I'm still fully committed to RLFTF, and adding a bit of our U.S. partner too (my shareholdings are also an 80/20 split in favor of RLFTF.)
Congratulations to the long-time supporters and new holders alike for their investment in HGEN. Looks like we patient investors (also known as stubborn, pig-headed, etc.) are getting our due.
New $LPCN article on Seeking Alpha:
https://seekingalpha.com/article/4394643-lipocine-imminent-catalysts-in-nash-and-oral-testosterone-replacement-therapy-make-for-strong
Very bullish.
No expanded access to experimental medicines not yet approved is not covered by Medicare/Medicaid to my knowledge. But medicines that have been granted EUAs are!
The EUA request that NeuroRx made with the FDA is specifically only for those at the same level of sickness as those in the expanded access program. I believe NeuroRx intended to try a Hail Mary using the ample existing EAP data and years of safety data to get the EUA in that population.
The ongoing trial does not preclude the FDA from giving an EUA for the EAP patients. The argument against this as I understand it goes: if the FDA gave an EUA for EAP patients, essentially expanding the EAP to all hospitals who wanted to participate, then people would leave the current blinded clinical trial (which is either at or extremely near completion) and the trial wouldn't fill.
The EAP is only for patients too sick with comorbidities that wouldn't qualify for the trial. This means that if people left the current trial, they wouldn't be eligible for the EAP anyway.
Another argument is that ethically, one cannot approve a drug while some patients are in a trial that could be getting placebo. Again, the patients in the trial are not the same category of sickness as those in the EAP. They couldn't get RLF-100 even if NeuroRx/Relief had an EUA for the EAP. Furthermore, the once the trial completes enrollment, in the next few days if not already finished enrolling, the point is moot. There will be a 28 day and a 60 day follow-up, but the trial is effectively locked as far as patients go.
So I maintain that an EUA for the EAP-level patients is still quite possible even before the clinical trial's full completion.
Amazing results! These patients were too sick to qualify for the randomized trial. Too far gone, having churned through all available options. The most critical of all, with comorbidities like organ transplants, heart conditions, etc.
They took all comers who had been lingering on vents and ECMO for sometimes weeks. RLF-100 saved them. 72% who received aviptadil survived vs a survival rate of only 18% in those not given aviptadil in these near death patients.
The pivotal double-blinded trial may be even better, since the patients are less ill, though 72% is extraordinary.
Here is an interview with Skyworth / Skywell founder, and DSGT / Imperium Motor Company partner Huang Hongsheng from 2018. It is a long interview, which suffers from Chinese to English translation issues that obscure the intended meaning, however that is what also makes it interesting.
For example:
"Interface News: I heard that the life of building a car now is very simple. I live in the factory all day. Do you think this is a process of enjoying suffering?
Huang Hongsheng: Lin Yutang said a word, our will is unforgettable. That is to say, a person's awakening height is just the depth of his suffering.
If people come to open their mouths, clothes to reach out, and live a very ordinary life, it will be easy to go outside the door under a lot of temptations. For example, if I know a friend, they make some money, they go to gamble, and then they go bankrupt, which is very tragic. Some people are too flat, paying attention to their health, constantly checking their bodies and killing themselves. So sometimes, the usual prosperous life surface is a temptation, it has traps.
On the contrary, you feel that sweating is a very tiring thing, but the health of the whole person has taken a step forward. So, sometimes your health, your success is to find a competitor to force yourself to die, that is suffering. Every morning I will get up at six o'clock, chat with different car people, know what new technology is developing, and learn from them. Of course, there are also many unsatisfactory things. These things have allowed me to focus on the spirit and face the solution. I think this life is very healthy and very interesting. Many of our retired classmates watch TV shows every day, and spend the day and night. Life is very casual, but it is very boring."
Huang Hongsheng has been in the EV space for a long time. Per the article, "In 2011, Huang Hongsheng reorganized and acquired Nanjing Jinlong Bus Manufacturing Co., Ltd., focusing on pure electric vehicle manufacturing. Since then, Nanjing Jinlong has quickly turned a profit and ushered in explosive growth."
This guy is the real thing. Skyworth is the largest TV manufacturer in China, and one of the largest in the world.
https://www.firstxw.com/view/214247.html
Of course they await an EUA to distribute beyond the Expanded Access Program.
What I appreciate about that quote is that it is realistic. When realistic numbers are stated that indicates we are extremely close to distribution. Contrast that with some others in this space that throw out wild numbers.
Nice interview, with a good amount of footage courtesy of NeuroRx. Well done. Thanks for finding it Macd1.
This is from last October, 2019. Just making sure you are aware of that. Also, the funds are to come after NeuroRx lists on the NYSE through a merger partner.
Especially the unanimous decision!
Javitt's title is "King of the World". Duh.
https://giphy.com/gifs/kbz6iLCGXDLgI/html5
Prediction made at 11:43pm in California: RLFTF will rise tomorrow, because the DMC has confirmed that RLF-100 will likely demonstrate superiority to placebo arm in 165 patients. This is based on a review of the 102 double-blinded patients.
The reason for the drop was a quote from a clueless Swiss firm suggesting that PhaseBio's trial halt bodes poorly for Relief. On the contrary, as explained by Dr. Javitt a few weeks ago, PhaseBio's drug targeted VCAP1, a vasodilator, while RLF-100 targets a different receptor, VCAP2. Apples and oranges. Those of us familiar with PhaseBio have been aware of this for a long time. The sell off started with the Swiss, so I'm assuming that they were not as informed.
The timeline is delayed. As an investor in a number of Covid-19 therapeutics, I've noticed this in every single one. RLFTF is no different. However, this polypeptide has the best data, in the most critical patients out there. I truly think that RLF-100 is going to be a magic bullet against this virus.
I bought 70,000 more shares yesterday, bringing my total to 770,000 shares. I've been around the block a few times. I think this one is for real.
Very well said!
I believe the duty to report for SIX (Swiss Exchange) listed entities is immediately after the transaction. It would not be before.
I personally don't think it was GEM doing this transaction (unless for tax reasons like aGuy suggests).
Rabbit hole material:
"ATS transactions within OATS are almost always double-counted because both the buy and sell side of a single transaction are reported as executions within OATS."
ATS = Alternative Trading Systems
OATS = Financial Industry Regulatory Authority (FINRA) Order Audit Trail System (OATS)
FINRA firms have a duty to report under OATS, so there is a double count for buy transaction and sell transaction.
https://www.sec.gov/files/otc-trading-white-paper-03-2014.pdf
I recommend one not go down this rabbit hole!
Could be anything or anybody! Not too long ago, before the discovery of RLF-100's amazing potential in Covid-19, the stock was so cheap it didn't take much money to have 7 million shares. Any one of those lucky stiffs could be lightening up. It could be an institutional cross, where one firm sells to another at a prearranged price. This is what I believe it was. If the trade was made by GEM, or a member of management of Relief, they have an obligation to report the transaction on the SIX exchange through the "DERP" form.
For those unaware of the way trades are reported on the OTC, if one party sells shares to another party, both sides of the transaction are reported in the volume. For example, if one party sells OR transfers 7 million shares to another, the volume of shares traded will show as 14 million. Trying to explain this as kindly as possible for those who are new to investing.
What is the Particle subsidiary working on? Will there be an actual product from Particle soon, or is it all development stage? Thanks.
Speaking of Strunk and White, I haven't yet read Dr. Javitt's novel Capitol Reflections, but it's VERY interesting to note the special thanks in the foreword includes one Dr. Scott Gottlieb, former commissioner of the FDA:
"Acknowledgments
I had a great deal of help in bringing this project to publication. First of all, I want to thank Billy Hamlin for his invaluable teaching and Lou Aronica for brilliant editing. Dan Troy, Mark McClellan, and Scott Gottlieb were generous in answering many questions about FDA’s inner workings."
Connections at the highest level. Dr. Gottlieb has been invaluable in communicating the facts about this pandemic since day one. Early on, I heard him and his network referred to as the shadow FDA, while the official FDA was busy spinning its wheels.
One of the best job listings I've seen. Certainly Dr. Javitt wrote it.
Thanks PennyWorld...The feeling you get when somebody has already asked and answered the question multiple times with greater specificity, accuracy, and alacrity.
Very well explained aGuyUS. I don't know if this was brought up before, but in his last interview Dr. Javitt said that the PhaseBio form of VIP has a different target. It attaches to a different receptor I believe.
Wrong. In fact, this will speed up a potential EUA.
Gee Gee, can you please repost this message. I can then stickie it. A message has to be less than 48 hours old to stickie. Mods have only 1 stickie available. I have removed the one I had, and now await this one.
As many of us stock researchers are, especially in the small cap world, I am a skeptic and a cynic, looking for the things that don't add up. Words versus actions. It is a constant battle with one's emotions.
But what your daughter witnessed in the lobby, I have no doubt, was a message to you and your family from your wife. We know a lot, but we don't know what we don't know. Thank you for sharing that with us.
Oh jay, I'm so sorry to hear about your wife. My deepest condolences to you and your family.
No doubt Humanigen is overwhelmed with the ramp up to be ready for the Covid-19 reprise that overtaking the world, though they are still managing to put one mab in front of the other with the CAR-T / yescarta trial. Really seems like HGEN will be a meal for GILD in the not too distant future.
Corning - what a legendary company! Did you work with glass or other substances? I think glass is going to become celebrated yet again for its amazing qualities. It's green, clean, and non-leaching.
when dOLphintOm talks charts, I listen. Glad to see him here in Humanigen!
Thanks for the info. I'm thinking a few of those analysts from the investment banks that put their clients into the latest deal (and the one before) are going to be weighing in very soon. After all, we're bonafide now, being on NASDAQ.
That is some top shelf humor! Well played knuckle!
Spot on in your thinking. High insider ownership, low float, and new Nasdaq listing will mean a quick rise to fair value if TOMZ gets some more press.
Well said Taemen. For an antiviral to work with Covid-19, testing needs to be done daily in those high risk environments, and the antiviral should be taken immediately, because once the illness progresses to the immunologic phase, antivirals are too late. The cost of such use will be extraordinary.
Thanks, just saw that. Here's another article: https://www.the-scientist.com/news-opinion/antibody-based-drug-may-reduce-covid-19-hospitalizations-study-67942.
"The company reports that out of the 302 patients given the drug, five ended up in the hospital, a total of 1.7 percent. This rate is a marked improvement over the 150 patients who received a placebo, among whom nine, or 6 percent, required a hospital stay. There were no reports of significant adverse reactions."
So that apparently is a 72% reduction in hospitalization requirement. On first glance, it doesn't sit well with me. Perhaps because there was such a small number of the population being hospitalized in both arms. 5 out of 302 vs. 9 out of 150. And I couldn't find reference to the P value.
Very true, PharmaBro. Baricitinib is not a MAB. I could only find reference to a one day improvement in hospital stay with the "cocktail" of Rem and Baricitinib, but not a 70% improvement.
I suspect such a combo of Rem and Baricitinib could also be used as an emetic, or a non-surgical liver remover.
Let the flogging commence! Yeah, point taken. In regards to some others, you are more charitable than I am, because I'm a bit tired of the pearl clutchers among us. Some people have obviously not invested in biotechs, or maybe are not used to holding a stock longer than a few days.
aGuyUS you have to be very careful with definitions and interpretations. My impression is that normally you are, but here you have widely missed the mark.
#1) EUA does NOT stand for Enhanced Use Authorization. It does stand for Emergency Use Authorization.
#2) The expanded access protocol does NOT allow ANYBODY on a respirator to get RLF-100. Their condition has to be such that they do not qualify for acceptance into the trial. Expanded access only accepts patients who cannot because of their condition qualify for the trial.