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Just think that instead of these fights, both RLF with it's AdVita and ACER had merged with NRX with it's NRX101 drug and a COMBINED EFFORT to COMMERCIALIZE and get APPROVED at EMA as well as FDA. Could have been a fair Pharma.
But NO, both heading to a toilet near-by...JMHFO...
Did Ifenprodil beat Remdesevir CT results. Rem again proven ineffective.
Will AGN Publish the results for Ifenprodil? O2/IL-6/Time on ventilators/recovery?
"Gilead’s remdesivir — or Veklury, as it’s marketed in the US — raked in around $2.8 billion last year as the only FDA-approved antiviral to treat Covid-19. But new data from a European study suggest the drug, which has been given to about half of hospitalized Covid patients in the country, has no actual benefit.
The open-label DisCoVeRy trial enrolled Covid-19 patients across 48 sites in Europe to test a handful of treatments, including remdesivir, lopinavir–ritonavir, lopinavir–ritonavir and interferon beta-1a, and hydroxychloroquine. To participate, patients had to show symptoms for seven days and require oxygen support. A total of 429 patients were randomized to receive remdesivir plus standard of care, while 428 were assigned to standard of care alone.
Researchers measured remdesivir’s efficacy on day 15, using the World Health Organization’s seven-point scale — only to find that no clinical benefit was observed in patients who received the drug over those who got standard of care alone. And while previous studies have linked remdesivir to a faster time to recovery, that result was not seen in the DisCoVeRy trial.
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Here’s how patients were distributed on the WHO’s scale:
Not hospitalised, no limitations on activities (61 [15%] of 414 in the remdesivir group vs 73 [17%] of 418 in the control group); (2) not hospitalised, limitation on activities (129 [31%] vs 132 [32%]); (3) hospitalised, not requiring supplemental oxygen (50 [12%] vs 29 [7%]); (4) hospitalised, requiring supplemental oxygen (76 [18%] vs 67 [16%]); (5) hospitalised, on non-invasive ventilation or high flow oxygen devices (15 [4%] vs 14 [3%]); (6) hospitalised, on invasive mechanical ventilation or extracorporeal membrane oxygenation (62 [15%] vs 79 [19%]); (7) death (21 [5%] vs 24 [6%]).
The results bring into question Veklury’s approval — and also its hefty $3,000-plus price tag.
The FDA granted remdesivir full approval back in October based on three randomized control studies, including the full data from the NIAID-sponsored Phase III ACTT-1 trial published on Oct. 8, according to Gilead. That study showed a reduction in recovery time by five days in hospitalized Covid-19 patients and by seven days in patients requiring oxygen.
Gilead had previously been granted a partial EUA in early May to treat severe Covid-19, which was later expanded in August to include all hospitalized adults and children after a Gilead-led study showed modest efficacy.
But the week before remdesivir was approved, the WHO released a study showing the antiviral had no substantial effect on improving mortality rates, reducing the amount of patients needing ventilators or shortening hospital stays. In this trial, remdesivir had no material effects on ventilation initiation or time to discharge.
In an FAQ, the FDA had said that since Gilead’s ACTT-1 study was randomized, double-blinded and placebo-controlled (whereas the WHO trial was open-label), they found ACTT-1 to be “better suited” in a time to recovery endpoint.
In April, Gilead CEO Dan O’Day said about half of all hospitalized patients with Covid-19 in the US are treated with Veklury.
For a look at all Endpoints News coronavirus stories, check out our special news channel.
US battery factory?
"and augmented with sustainably mined material."
Quebec has world class Graphite at with "Green" footprints; GBM, NMG MGPH.
https://insideevs.com/news/533378/redwood-materials-100gwh-recycling-plant/
Where else?...GLTA...
There is still the IPF/CC Trial with Ifenprodil. It may have data that relates to some from AGN COVId results. We already see the Tumor reductions now targeted too for Cancer.
The latest Stroke news from micro-dosed DMT showed much faster work than I expected there.
An aggressive BOD may help. Connections, eventual partnerships for both drugs?...GLTA
Now the FDA/Big Pharma is going after 5 to 11 year olds. 2 months of data?
Looks like the FDA was never interested at all in repurposed drugs or alternate solutions for Treatments except a Big Pharma's like Gilead's Rem (Wuhan V I).
Moving on with Ifenprodil to a Phase 3 wasn't going to work for us, or for any treatment drugs.
Reread the Rem data and compare it to Ifenprodil, O2/IL-6/time on ventilators. Maybe AGN could find an interested partner for ARDS or other lung disease treatments.
But the intentions for COVID in the FDA are clear, Big Pharma Vaccines or Treatments ONLY... Some of the top folks that approved the vaccines have already taken jobs at these BPs...Sad...
https://finance.yahoo.com/news/1-u-fda-may-authorize-162334334.html
2 months of data for approvals of vaccines for 5 to 12 year olds. Money influences decisions apparently.
https://finance.yahoo.com/news/1-u-fda-may-authorize-162334334.html
Money influences decisions again... Great needs but delays for alternate solutions at the FDA...
https://finance.yahoo.com/news/1-u-fda-may-authorize-162334334.html
We all should have followed Tony out the door. This was a leading first to market CBD company with Prana products, cold extraction and multiple partners. fuckt up by personal greed and dilution for bonuses.
Idiot was bragging about using some Amazon tribal drugs and obviously lost his mind/failed in company directions and lost our money.
A final FOAD...GLTA somewhere else...
Add this to ONT, IMSC, ESPH, EVTN etc in my circular money burner file can.
A Martha Stewart story BS charge?
LtQ North was a hero.
I am happy with a 'hard charger' on the BOD.
Let's have some Pump and PPS move-up.
JMHFO...GLTA...
Thanks for posting that PR. Certainly one of the best written and informative.
Nice to see several things accomplished. Nice to see Dr Strassman involved.
...GLTA,,,
They should have merged last year...NRLA...
But GREED and STUPIDITY will push these to the Courts now...
Beyond all that, a Clinical trial should have a 'peer reviewed' publication of results.
Shareholders paid for it.
Just like the Dr Yost research being used now by BLO and what he took to Bellus.
Dr Williams was Well Paid for his Drug research when BTH re-merged with NASH and an evaluation including a final 'paper' is owed. If he will not/does not give some peer reviewed report, the new CSO and teams should, IMO.
The CT had this BS...
"Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided"
We can 'HOPE' there is IPF/CC data for Ifenprodil that is confirmed by data from the COVID CT. Combined there may be 'significant' results.?.
Enough to sell? Partner? Pump?
Tumors/Cancer/PF/ARDS.?.
...GLTA...
The claims of Ifenprodil helping low O2 patients and the IL-6 affects were somehow dropped with the 'no phase 3' trials for Ifenprodil.
This was a company decision, the FDA did Not say it was futile/ineffective or had safety issues, Right?
Both these were claimed to be at significant data levels. Many felt that there were follow thru possibilities. I guess AGN is supporting the IL-6 Tumor data from these results to combine with the work from Dr North.?.
Sure we may have to accept the issues of cost and waning COVID needs for not advancing to a phase 3 trial. But, IMO, we should expect a publication of the data that WAS found. Good or Not.
Ifenprodil for ARDS / IPF is related to the data collected from the COVID trial, IMO. Such a huge investment of Company/shareholder money and Time deserves a publication of results.
Maybe there is Something that can be marketed from this Ifenprodil Trial... Seems just like the Breathalyzer after Dr Yost left, just dropped instead of an effort to progress or profit from all the work. Certainly less info and respect being shown to investors.
"Still believe that Relief And Neuro need to work together"...Unfortunately this Wont Happen, IMHFO...
The time is passing-passed and there has been so many pumps/waves that have morphed into battles/back-stabbing and now will end up in court. A disaster for both company's created by Greed, EGO and stupidity.
JJ could have worked together with RLF and formed a partnership like my suggested NRLF. India makes it's own Remdesevir, why not Buc and VIP too.?...
Now NRXP/RLF will suck hind tit to Big Pharma therapeutics IF RLF/Zyemini ever makes it to the dance. I believe they already have an answer from the FDA. Maybe the Inhaler RLF Trials will have significant enough results. RLF "science officer" or JJ posting on obscure PR sites WONT cut it. IMO...
BUT, JJ and Danial are RICH NOW, so WTF do they care? Slimed Betrayals, JMHFO...GLTA...
And I thought that they would surprise us with 'good Interim data' / un-blinding of at least 600 at this Aug 25 + date...GLTA...
Topotecan has a commercial name of Hycamtin made by Novartis.
https://www.novartis.us/sites/www.novartis.us/files/hycamtin_inj.pdf
Maybe they are interested in Dr North's results. Maybe they already know? AGN licensed the MOA. Partnership Dreaming?
Significant results with the combination of Ifenprodil with Topotecan.
Dr North research
"Xenografts from mice receiving a daily dose of Ifenprodil (2.5 mg/kg) over 10 days decreased their size by ~30% and maintained them at a size below that at day 0 until treatment ceased at day 10. Afterwards tumors began to recover and grow but at the same rate as control tumors (P<0.001). 2.5 mg/kg is considered a well-tolerated dose and did not impact the health of the animals.
Xenografts from mice receiving alternate day doses of Ifenprodil over 9 days (2.5 mg/kg) or topotecan (days 0, 2 and 4) showed slowed tumor growth compared to vehicle-treated controls so that each agent restricted the rise in tumor size to about 2.5-times by day 16, while controls rose to an average of 9.2-times. Tumor doubling times were 4 days for controls, 9 days for topotecan treatment, and 12 days for Ifenprodil treatment.
Xenografts from mice receiving alternate day doses of Ifenprodil (2.5 mg/kg) plus 3 mg/kg topotecan on days 0, 2 and 4 seemed to arrest all growth over the 16 days of observation, and the tumors of all individual animals behaved in a similar manner with little scatter. From this study, there was clear addition through the topotecan and Ifenprodil combination (P<0.01) with marked synergy for smaller tumors (P=4.7E-4)."
I was looking at the Turkey and Swiss Inhaler Trials. Yes at the start of that one too it was Aviptadil until it was JJ's...GLTA...
https://clinicaltrials.gov/ct2/history/NCT04360096?A=1&B=8&C=Side-by-Side#StudyPageTop
https://clinicaltrials.gov/ct2/show/NCT04844580?term=aviptadil&draw=2&rank=3
https://clinicaltrials.gov/ct2/show/NCT04536350?term=aviptadil&draw=2&rank=2
It appears that these are Aviptadil Clinical Trials Not any mention of NRXP or Zyemini. Hmmmm, Maybe I'll Be back...GLTA...
There will be more than a single site and they all use the same protocol. Most Cts have several sites (including AGN COVID).
I dont understand Australia either. Novotech apparently thought they could recruit the patients necessary. A lesson, so CM's cautionary statement was so folks wouldn't expect instant results. It's Their Jobs to ensure recruitment/IPs/Data collection methods, ect. Recruitment for COVID went OK .
Plan and apply to the FDA Phase 1 ASAP. Design a plan for Phase 1/2 for both SCLC and Pancreatic is a big job.
Partnering with ApeX/topotecan targeting tumors would seem part of the Dr North path. IMO...GLTA...
Seems like the plan is Cancer/Ifenprodil, Phase 1 and 2. Identifying cancer stage/targets/Trial site(s) along with the proper CT design is a priority now under Dr North. JMO...GLTA...
My point was seeing Ifenprodil as a cocktail/'other drug' with Topotecan is possible. The shortest path with easiest finances.*
I see possibilities and so should our CEO, especially with Dr North's guidance and connections.
As an investor I am happier with Ifenprodil's uses for Cancers and lung issues (even stroke) than DMT for anything.
* Yes, low chance of Ifenprodil Phase 3...GLTA...
Better to be an 'other drug' under topotecan than to fight through independent Trials as a stand alone drug.?. 50% decrease in tumor size with ifenprodil...GLTA...
This one didnt post ...GLTA...
FDA: Topotecan hydrochloride is approved to be used alone or with other drugs to treat: Cervical cancer that has not gotten better with other treatment or has recurred (come back). It is used with another drug, called cisplatin.
Topotecan Hydrochloride - National Cancer Institute
www.cancer.gov/about-cancer/treatment/drugs/topotecanhydrochloride
www.cancer.gov/about-cancer/treatment/drugs/topotecanhydrochloride
Yes, it would be nice IF one of the Sponsors of current Clinical Trials involving Topotecan took interest in the success the combination with Ifenpordil makes. Someone else? Could happen, this is just a pretty GOOD start, IMO.
At least I dont expect an instant partner. Possibly/Maybe there are things being accomplished besides the current PRs. At the least a pp is now possibly $.10+ instead of a <$.05.
Valid Cancer work supported by Dartmouth with Dr.North's connections in place now is something to market and Build on...GLTA...
BTW2
Is Topotecan marketed in the USA? Canada has ongoing Clinical Trials.
https://www.apexbt.com/worldwide-distributors
I had thought there was the opportunity to form a combined company with both company's drugs including a combined effort to develop IV RLF-100 (and Inhaler/Dry powder/thin film), the actual "JEWEL" and what was used in the Clinical Trial.
I called it NRLF. Acer/Advita/NRXP/RLF.
Obviously Greed and Betrayal has ruined Any hope of that, so I've been out.
So sad, QUICK Cooperation AND Combined Efforts could have been something. Now.?. IMHFO...GLTA...
Ifenprodil has passed the Phase 2 approval stage for dosages, identifying effective results and overall safety.
Will FDA recommend that these Cancer / Tumor Trials for Ifenprodil possibly be at the Phase 3 stage?
...GLTA...
Significant Ifenprodil News on a Monday?. So, Maybe something tomorrow too?
IPF/CC enrollment completed next?...GLTA...
I took the mRNA vaccine but I feel the decades of research using adenovirus tweaks has less possible long term dangers. J+J was stopped for 6 cases of rare BP issues. There have been deaths, complications and unknown long term issues with mRNAs. For a Cancer patient that risk is NOTHING, but for a young healthy person I can understand their concerns about taking mRNa vaccines.
J+J vaccine is much more stable and does not need sub-zero storage so it would be Much easier for some areas.
Many here post they wont Vac anyway.?.
Either way,,, I will certainly take J+J CASH/SHARES if they want to make a deal. MF will probably ALSO sign a deal with J+J if offered.
""Johnson & Johnson: The third vaccine to receive emergency use approval in the United States uses another relatively new vaccine technology that tweaks a harmless adenovirus — a type of virus that causes a common cold — to deliver the coronavirus spike protein instructions. After decades of research, the first adenovirus vaccine — used to protect against the Ebola virus — was approved in July 2020. Scientists reengineered the adenovirus in the COVID-19 vaccine so that it cannot replicate and make the recipient sick, but it can still deliver the spike protein instructions."
J+J was less of a winner in COVID compared to PFE and MRNA due to the media exaggerated BP issue with older females in their vaccine. It was better and had easier logistics with No need for the sub-zero storage and transportation.
J+J is also more of a 'local drug store' recognized name. They may want a Big and FAST SPLASH with lots of MEDIA and a focus beyond the vaccinated US (etc), IMO.
Good Interim data May be enough to start it, IMO.
A Safe PILL for non-Hospitalized Patients at your local store...GLTA...
PS. Cancer Mabs are fine when there are few choices for life, just like a serious COVID patient. Their effectiveness is not universal as seen by recent FDA limitations on the uses for Keytruda/Yervoy/Optivo. Remdesevir (virs) have their dark sides too. But mabs as a vaccine for everyone? Hmmmm.
I took my shots early as I was 'high risk' and have done all those cancer drugs including Interferon, 4X survivor. I was not worried about side effects. Many younger folks may have different views.
My psyc was supported by regular Pot use and 'liberty caps' on occasion.
Come On J+J. Grab this market with Buc.
I had read that much of that research at the VBI was funded by Gilead and their research of Remdesivir's development and effects on these viruses.
Another treatment also with long IV Infusions and BP/Expensive have been approved but are also basically ineffective too.
Now vaccines by BPs.
No incentive for 'them' to support simple solutions. No inside conspiracy theories here. I took my shots early in a line almost like the Army 40 years ago. Trained. Long Buc and schroomz..GLTA...
Use for other indications would be great and the implied effectiveness for these other issues can be seen in some of the COVID CT data. Unfortunately the only CT is for COVId. Prescribing VIP for other issues would need separate CTs, IMO.?.
Either way it is a long way still to worry about profit shares and large MCs. There is still $0.00 sales @NRXP/RLF, just production for Trials so far.?. Plans and R+D and JJ/Dan got rich.?.
It's sadly obvious that BPs' control the FDA.
Gilead/Bat Soup/Rem/Wuhan/COVID.
EXPIDITING Dry Powder Inhaler will need a CT Too.
PFE will have $33B in vaccine sales with a MC of $240B. Do you think rlf will be worth 1/6 to 1/3 of that? ($40-$80B?) Is $8K a dose (X3) reasonable?
The possible production increase of RLF-100 / Zyemini implied a lower overall cost and better access. With NRXP only entitled to 20% of the 'Rest of world' business/profits, the huge decrease in the US cases (NRXP areas) and moderate interest by many countries (at best)... Will there be sufficient Efforts made by both RLF and NRXP to create and supply the Market? Actual distribution? Solved logistics? Enough Available patients at the highest level of need?
IDEA #1. Get the dry powder Inhaler figured out ASAP.
Long infusions or nebulizing the current IV formulations are subject to the same tough and expensive sub-zero logistics as PFE vaccines.
PFE was only able to distribute their vaccine with HUGE help from Govs. Pre-paid.
This exciting news should really bring interest here. Dr Nutt said he feels a 3 on the 1-10 scale about DMT/stroke, maybe a 5/6 after the pretrials. Guess he's not at the "Conference"? Phase 1 pre-trial work to start?
Closing the books on COVID seems due to a waning need. BUT, is there any significant data from that Clinical Trial. No peer review? Was the data AFU? Was there significant O2 and IL-6 data? Was Ifenprodil data strong enough to support other CTs?
6 more patients needed for full enrollment on IPF/CC. 20 patients...
The current inhaler CT is using the 'nebulized' formulation of RLF-100. 3 X a day 100 ng. Kind of hard to dose patients given the short 1/2 life of VIP and the logistics of it in this sub-zero formulation. (60 day shelf stable @-5 deg C)
The Dry powder is the ticket but I have not read when it will be ready or if any of the CTs are/will be using that formulation.
FDA Transition Plan to “Ordinary Course” Approvals
Even as regulatory oversight gradually reverts to more normal conditions, many EUAs will not be short-lived. Indeed, if past practices are any indication, “emergency conditions” will likely persist for a while yet, as evidenced by the prolonged Zika and Ebola emergencies. Indeed, at a May town hall, the FDA indicated that they do not expect the emergency to be declared over “anytime soon.” It is therefore possible, if not likely, that the COVID-19 state of emergency will persist for several years, and the relatively fast-tracked EUA approval process will remain a viable option.
https://www.jdsupra.com/legalnews/fda-regulatory-approvals-as-the-u-s-2918816/
Besides a large % of the world wide population that does not have access yet to any COVID vaccine, there is the group that will not take any vaccine. Many of these people may want a therapeutic such as RVV's Buc available...
Masks have been worn in Asian countries for decades mostly due to pollution, but that seems to have helped them adapt and have lower infection rates until recently when air-travel and tourism has reopened. Wearing a mask, vaccinated or not, is Not a bad plan for personal protection.
Yes, COVID (etc) will be around...GLTA...
Well, the USA has reached the #1 spot again. Should be plenty of patients again. The world is back over 500K a day and climbing. 80% of countries do not have enough vaccines even for health workers. 25% of US health workers refuse to get vaccinated.?...
https://www.worldometers.info/coronavirus/
Seems the CEO is saying that data from the COVID CT can be used to support new CTs for Ifenprodil in the future? ARDS/PF??? Ifenprodil IL-6 effects on tumors? Low O-2?
I also wish CM would mention 'micro-dose' when discussing DMT so as to leave out Psychedelic and separate AGN from the crowd.
"Algernon’s decision will not affect any of its other research programs including investigating Ifenprodil for other disease indications. Algernon has several clinical stage programs currently in progress including a Phase 2 trial of Ifenprodil for idiopathic pulmonary fibrosis and chronic cough. The Company is also planning a Phase 1 clinical trial for the psychedelic drug DMT and stroke by the end of October of this year, as well as a Phase 1 trial for pancreatic cancer in Q1, 2022."
Apparently they have not had the time to review Ifenprodil for stroke or considered combining with micro-dose DMT for preclinical trial. YET? Still holding some BTH shares and watching. Another 'quiet time' until Oct?
Lucky they all got their 424 forms done before the spike. JJ/daniel - GEM - BRPA investors. Not even some follow thru as a fake out to keep interest...JMHFO...
Re Present data to investors and still digging for other barely 'significant data' from some patients to give to FDA. Why not 90 or 180 day data? Maybe some more data not found during initial reviews of CT data.
(convoluted/ineptly run by JJ/Dan)...
Does anyone see +$30 for this or +$1 for RLF in any near term evaluations?
At this point I see huge a reason for an NRLA merge (NRXP/RLF/ACER/etc). But. RLF may have better luck independently?