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How about Kal and friends arrange for the purchase of BTH IP for medical uses by BLO. Dr Yost stole much of the combined IP from UF that both BTH and BLO (read shareholders) Paid for.
AGN needs some ca$h and BLO needs new directions, especially with Unions/DOT/courts/ect having strict procedures already.
IV was for COVID only.?. The Inhaler is 3 X a day for 10 days, however 100ng takes for nebulizing per dose. 1/2 life of VIP is short, < 5minutes, so the long application seems necessary for the current formulations that are being used in all trials. ARDS and PF are endpoints now too in these later Trials. Dry Aviptadil is a while off from what I read...
Seems JJ et al are re-announcing presentation of the data with 60 day results included. A lot of NRXP volume yesterday, probably some from JJ/Dan and GEM/BRPA.
Who is speaking for RLF? When? EMA? Sub zero logistics?
The 12 hour infusions help with cycloids that seems due to the continued length of TIME their VIP formulation is applied to the body. Because of the short 1/2 life of VIP. Nebulized Inhaler seems to be applied that way too which would be much easier than IV 12 hour infusion. Then...Maybe...
But... $25 X 3.6B OS = $80B, maybe you meant $2.5 if everything plays out.
Logistics of use/DEMAND/storage?
Cost?
AGN had good Il-6 and low O-2 significant data. BS or is that real?
The decision to not go forward with Phase 3 because of costs and a waning COVID pandemic seems almost logical but to say data was not strong and just DROP Ifenprodil until after IPF/CC data???
Another stock is running well on weaker data for IL1 and IL-6, but they followed patients to 60 days to get something to present. (Mostly fluff, IMO) 195 patients and AGN treated 165.
Yep. screwed us hard with no Real explanation - no comment on what went right - no direction - and putting a snuffer on Ifenprodil by saying weak data??? WTF???
I have avoided bashing, butt, WTF? Inept? Stupid?...GLTA...
https://www.globenewswire.com/en/news-release/2021/05/12/2228023/0/en/Algernon-Pharmaceuticals-Announces-Ifenprodil-Reduced-Interleukin-6-in-Phase-2b-3-COVID-Study.html
https://www.globenewswire.com/en/news-release/2021/03/31/2202350/0/en/Algernon-Pharmaceuticals-Announces-Topline-Data-From-its-Phase-2b-3-COVID-19-Trial-of-Ifenprodil.html
Selling Security Holders JJ + Dan 4m, 2M GEM...
Volume @NRXP?
https://ih.advfn.com/stock-market/NASDAQ/nrx-pharmaceuticals-NRXP/stock-news/85566647/prospectus-filed-pursuant-to-rule-424b3-424b3
Ifenprodil may get FDA approvals...GLTA...
GEM is also the largest investor in NRXP. GEM wants to start getting PAID for their support, ASAP.
A combination of NRXP and RLF and their new subsidiaries would make a nice midcap Pharma, IMO. The prices are right for GEM to support a NRLA, IMO. NRXP+RLF+ACER++=NRLA...
They 'could' force this BS feud to end. JJ is 'RICH' now so maybe there could be reasonable common efforts. Sad this has fumbled so often, had cumulative delays, problems with some Data which resulted in less than stellar results and lack of cooperation.
A consolidation of Drugs and shares structures and debt and talent might be the answer to again attract interest without this current BS...JMHO...
Yes, in good hands. The world is a great target now instead of just North America. The USA has finally handled COVID thru social distancing, masks and now vaccines. The rest of the world is now suffering along with variants' issues.
Certainly a strong idea to partner with Supryia for the most immediate approvals and to reach the largest markets.
Sign that Royalty and Licensing deal ASAP..GLTA...
https://finance.yahoo.com/news/revive-therapeutics-partners-supriya-pursue-123800465.html
Australia has been closed to foreigners and is again.*. Efforts and priorities for AGN had changed from IPF to COVID by Mar 2020. The Nov 2019 PP money was directed toward the IPF/CC. A second PP financed the COVID CTs. Most know that already.
A claim of the CEO lying may be slander and if he did it would be dumb but very had to prove. COVID issues were and are a main delay there too, IMO. Surely there was small chance of an AGN CSO or even the CRO to go to Australia and help expedite any issue. The money is already spent there and raising more does not make sense to me at this point. We assume the IPF/CC is still being attempted.
Right now Shareholders are disappointed with the IPF progress but most are waiting for FDA results, IMO. AGN and shareholders also needs patience. Some sold obviously and some bought back. That's trading the news.
The FDA will release the meeting results to the company around day 70. Idiopathic PF and COVID lung ALI seem related to me. Ifenprodil MOA/efficacy and safety of the drug in those situations of ALI is the target. IMO.
I bought back due to my faith and DD in Ifenprodil. I hope results will allow fair financing for a future CT for Low O2 patients (long-haulers?) from COVID and ALI. Without FDA support Ahh-shits.
AGN is not a Big Pharma and shareholders WONT easily be convinced to accept futher dilution to fix issues. Seems to me this small company is doing better than most/all of it's direct competition.
With good FDA support there is a fair possibility for a partner. A direct $2 buyout chance was Blown by inept Interim evaluations and presentation along with the current COVID decline, IMO. CM has said we will ride Ifenprodil if possible.
I hope they are investigating the recent Stroke data found for it too.
IL-6 effects on Tumors may also be a Phase 2+. IMO
Putting a marker down for DMT microdose enables that future and having support from Strassburg ect brings credibility there, IMO...GLTA...
*
PS, Australia... https://www.straitstimes.com/asia/australianz/half-of-australias-population-in-lockdown-as-delta-covid-19-variant-spreads
PS2
IF 'team cobra' was scamming or smart they would have had BLO buy the Yost/Breathalyzer through their control. Could have been an easy 'paper' deal. But Kal is a pretty strait, X Cop, IMO.
Your opinion has been well documented.
I would think it would be a nice licensing or royalty partnership. Supriya as the manufacture...GLTA...
None of the other small cap pharmas have been successful running a full Phase 2 trial. I agree, we have a possible Winner here Smoki.
Ifenprodil has proven effective with helping patients with low O'2 levels and IL-6 issues. These results may have benefits for other patients besides for COVID and long-haulers. Acknowledgement of these results by the FDA will certainly make future plans of financing for Ifenprodil and/or other paths AGN might follow easier. Success will build confidence, IMO.
The obvious Dec Interim data presentation failure and inept evaluation of that data has been hard to overcome. We can hope that the presentations to the FDA will be complete and competent...GLTA...
Thanks for the IL-6 comparisons. Ifenprodil has shown much stronger results. IMO...
CEO's dont go places and recruit patients or anything like that, IMO. A CSO's JOB might be to have helped expedite recruitment if 'they had time'. Maybe even waited out quarantines in that effort. Probably difficult situations were involved in Aus/NZ/SK. OMG...
A Halt' is called to distribute Info. or CYA. Possibly a CSO might suggest that a halt would be beneficial due to research or data. A GOOD CSO might review data with great care/ before a Milestone presentation related to that research. Statements like "we see sort of a trend on some other stuff" might be better thought out when a CEO hands the 'Mic' to a CSO. JMHFO.
A CRO might have 'in person' at the site of a CT the company is running to expedite recruitment and ensure CT would be run as designed and the data collected is complete.
I hope for Ifenprodil - Micro dese DMT for Stroke as a possible research target.
The CEO and CSO have brought in KEY DMT scientists to advise...
Kick back dudes, we all have placed the bets and await the flop. We dont run the company, we just can buy - hold - or sell their stock.
The CEO just MAY get a fair or Better hand to play for us investors,,, finally. We are a Spec so far. That May change...GLTA...
Fly, VFDs with PWM controls are established science for MANY different applications like specialty motors for power and/or precision positioning done with integration of lazar or linear scales and encoder feedbacks... I like that kinda stuff and will read more, Butt...
We will see what the US FDA says about the positive O'2, IL-6 and other data results seen for Ifenprodil.
I wonder if an EMA application may be next. Romania had a lot of the COVID patients that were in the Trial.
Speculative investment, BUT you cant win if you don't play.
I hope for something about the Ifenprodil / Stroke data you found too. Maybe a combination with micro dosed DMT in the future.?. Maybe some pre-clinical work?
I've added 50% more at these 'dime' prices recently too.
...GLTA...
"Algernon Pharmaceuticals Inc. (CSE: AGN) (OTCQB: AGNPF) has received all the necessary permits and licenses for the manufacture of a cGMP supply of its proprietary DMT formulation, called AP-188. As a result, the company will be able to move forward with a phase 1 study of DMT in the emergency treatment of stroke."
emergency treatment of stroke."
emergency treatment of stroke."
Good find...GLTA...
JJ knows exactly what he's doing. So even at this pps, half the proposed BRPA deal price, he is sitting on $400M. He's done/successful/rich.
Shareholders here and @ RLF have been continuously screwed unless they have flipped to a profit after one pump or another. The feud and costly Delays seem to continue.*
I Expected!!! that the EAP data had been crunched already and presented WITH the CT data.
FDA may take as long as two months from application and NOW they will have to review the EAP data as 'supplemental supporting data' as well. More delays.
Questionable EUA may now need changing to full FDA approval review, IMO.
The Inhaler is using a slightly different formulation of RLF-100 IV.?. More shelf stable 'nebulized' formulation, but still needing sub-zero logistics.
They NEED to show Progress on the 'dry powder' formulations for future Inhaler use and CTs...ASAP.
Are ALL the data sets finally given to RLF for EMA? Will JJ stick his **** into that too?
*Historic betrayal issues.
IV Zyemini / RLF-100 needs logistics for sub zero storage too. That is what the Clinical trial used.
Are the Inhaler formulations being used in the current CTs the 'dry powder'?
He admits they bent the rules and redirected endpoints to other targets. The US FDA and EU-EMA should be ashamed about their conduct over the last year and a half. So much more could/Should have done.
Successful Clinical Trials should have strong support with the FDA and allowing the expediting of a Re-purposed Drug with a strong safety record.
An relatively inexpensive Pill instead of infusions.?.
The Big Pharma controlled FDA/EMA just changed things for an Alzheimer's drug why not approve COVID/ALI Drug on good Interim data trends with their CT too.?.
The Buc Clinical Trial is using a 28 day following of patients*, so there are a lot of people that have completed their treatments. Is 400 a good point to do an Interim?
The FDA / EMA SHOULD be looking forward with allowing support for treatments, as working with India will be, IMO...GLTA...
* I hope some are followed further as MF implied with mentioning long Haulers.
FDA seems to be moving the 'Bar' when Primary endpoints are not significantly data supported, well at least for BPs.
https://finance.yahoo.com/video/fda-shifting-bar-approval-alzheimer-135711267.html
RLF 57% of OS @ institutions / Insiders. NRXP about 70%+ insiders. +=+=+=
Roll this all up in "NRLA" and get moving as a combined Mid Size Pharma. Put ALL the pieces together dr JJ / GEM. I'll invest in That...GLTA...
FDA seems to have lowered the Bar for EUA... Well for Big Pharma's anyway...MAYBE...
https://finance.yahoo.com/video/fda-shifting-bar-approval-alzheimer-135711267.html
The new MF article had mentioned several endpoints as related to BUC and COVID 'Related' successes for BUC. Long Haulers!... India / EMA / FDA??? ...GLTA...
FDA... Shifting the Bar?
'Moves of biomarker was enough', 'Primary missed but reviewed data showed'... = EUA...
https://finance.yahoo.com/video/fda-shifting-bar-approval-alzheimer-135711267.html
...IL-6, O'2...
Manufacturing plans and capabilities are a requirement for FDA EUA consideration. Right?
Other drugs require huge logistics like sub zero storage. Or long intravenous infusions.
I would guess India sees this. Better to partner there than ?*?.
A simple Pill that works for Lung infections. Buc.
I hope you are not including ME. (Your PM about 2-4-21 + posts?)
I have provided links and been mostly positive until I recently sold most in a reflex to the AM/BS from JJ about EUA application at the Last possible second and the "best path forward" from RLF. I'm not a whale.
Folks scoff at my NRLA combo but what is left Now? Court?
I have seldom posted since taking some losses. I have also avoided posting this info/my thoughts @nrxp(JJ=60% of nrxp). I had a hope that there would be good volume there ALSO and the PPS moving toward the BRPA max offer of $30. I bought when NRXP @ $22 when I sold here. Lucky I sold @ crazy spike to balance, and @ $60 way back..
I now fully expect the RS and some groveling deal with NRXP. @$15 / $1.5 (post RS). 3.5B OS.
If after the 'dust settles' and it's higher maybe I'll chase here but JJ will make SURE HIS nrxp goes first. Now I expect to maybe hear something in a month. Or IF NRLA seems possible, I'll be back strong.
Shareholders complain about no news for months yet this possible violation was reported.
BY JJ? IMO. To enable him to steal/side step/obfuscate RLF-100 patents while being busy fighting. The Scam artist already has 60% of NRXP, PAID. The REAL LIAR has been JJ, IMHFO.
Apparently you too. But no comments about MY posted subjects, Ifenprodil/DMT for stroke and Ifenprodil for tumors/Ifenprodil for ALI, the current and possible future AGN focus and efforts.
Same wine, stale by now.
Shareholders can only Buy, Hold or sell a stock, we dont run the company.
>>>but I'm bored, so
#1, well within the PR time frame for EOP2 news.
#2, obviously after #1 success. Defined as low O2/ALI/fibrosis/IL-6 endpoints for Phase 3, IMO. Very marketable stuff.
#3, Ask Dr MW who ran the Aus CT and CRO Novotec, the CEO managed the cost and PP 11-19.
#4, S Korea. Ask Dr MW...
#5-oldies/
#6failing IYO/
#7mediocre/
#8, only Volunteers 'work for free'
/#9/#10, read the book,!, movies leave too much to visual interpretation.
Read Shogun - Taipan - Noble House ( in that order ) for compelling intrigue. Then check back in...JMHFO...GLTA...
Keva, I wanted to repost the link.
Also a couple of 'significant' quotes from recent PRs to go along with the Ifenprodil/stroke "nugget" you found.
https://pubchem.ncbi.nlm.nih.gov/compound/Ifenprodil
>>>
The Company has decided to expand its clinical investigation of Ifenprodil based on the drug’s significant effectiveness in treating a number of diseases including cancers, chronic disorders and psychological disorders such as addiction and PTSD, in certain pre-clinical and clinical studies. Algernon also recently announced that Ifenprodil, in its multi-national COVID-19 study, significantly reduced interleukin 6 (IL-6) at day five in the 20mg treatment arm, compared to the standard of care group. IL-6 is a pro-inflammatory cytokine and its involvement in multiple disease indications has been well established, including PC where its over-expression is related to poor survival.
https://www.globenewswire.com/news-release/2021/06/03/2241141/0/en/Algernon-Pharmaceuticals-Launches-Pancreatic-Cancer-Clinical-Research-Program-with-Ifenprodil.html
>>>
The animal study from the University of Szeged in Hungary showed that DMT reduced the activity of some of the mechanisms and effects that are involved in the damaging biological cascade that occurs after a stroke. In addition, DMT, reduced the volume of dead cells and increased the viability of cells found in the somatosensory cortex, all with statistical significance. One of the study’s authors is Dr. Ede Frecska who recently joined Algernon as a consultant to its DMT stroke program.
https://www.globenewswire.com/news-release/2021/05/27/2237256/0/en/Algernon-Pharmaceuticals-Highlights-New-Animal-Study-Showing-Effectiveness-of-Psychedelic-Drug-DMT-in-Treatment-of-Stroke.html
We see the RVV related news as shareholders well before major news outlets will have a chance to spread this. The COVID market has moved Time to buy? Many might see this news and decide, Yes. Buc/Thiols are established science. BP owns the FDA and influences their priorities. IMO. Expanding outside the US FDA is a very good move, IMO...GLTA...
India does not seem to be contingent on any US FDA actions. They move Fast there and are proudly separate. This could be moving in Days, IMO...GLTA...
Great Document Keva. Good read about the science of Ifenprodil.
Possibilities for AGN.?. Why Not another CRL 'pre clinical study Arm' for the combination of Microdosed DMT and Ifenprodil? Can their effects be complementary. A Good CSO and Research team may find correlations.
" Altogether, our results suggest ifenprodil improves long-term neurologic deficits through antagonizing glutamate-induced excitotoxicity."
Ifenprodil Improves Long-Term Neurologic Deficits Through Antagonizing Glutamate-Induced Excitotoxicity After Experimental Subarachnoid Hemorrhage
PMID 33713028; Translational stroke research 2021 Mar; ?(?):
Name matches: glun1 ifenprodil
Surely an interesting possibility...GLTA...
Sad Truths of CSO failures. IMO.
"If anyone here or who comes along can't understand these posts at ihub are our opinions...well that's their problem. I sleep well at night."
Apparently there is a need for 65 out of 100 opinions...
The current CSO and Team apparently had to Run the trial and I am happy THEY gleaned Positive results from the CT that THEY will be presenting/discussing at the EOP2 FDA meeting.
My Sarcastic point was the incompetent deserter apparently wont be there to represent AGN and his years of well paid for work and our investment. *
maybe I'm wrong and he appears. Hope Not.*
But he wasn't involved anyway.?.
MW apparently was missing at AGN a lot and now he left, You posted questioning his 'other interests' starting last year.
JOB @ AGN, INCOMPLETE.
*/*OR FU another presentation.
We wont be at the EOP2 FDA Meeting. Probably Dr MW wont be either, to represent his well paid for Work. Other's will be presenting OUR case to the FDA that have gleaned 'Significant' Data missed (?) by the past CSO...
Our Strongest cards for Ifenprodil and AGN. IMO.
I'm INVESTED in the bet AGN CEO C.M. is able to pull off a success. Defined as a Phase 3 directed at patients existing with low O2 / ALI / and maybe Pulmonary Fibrosis all from COVID. Now THAT would be a Marketable Hand...GLTA...
BTW, other popular companies are applying for EUA with less than 200 patient CTs. None with the sound science and Safety of Ifenprodil. IMO.
The latrine lawyering skills of some are impressive. Most LLs post with an IMO... IMO...
Ifenprodil was already 'Green Lighted' to move on to Phase 3. The EOP2 FDA meeting is to determine WHAT Endpoints will be the target for the Phase 3.
Pass.
https://www.globenewswire.com/en/news-release/2021/01/19/2160593/0/en/Algernon-Pharmaceuticals-Receives-Green-Light-from-DSMB-to-Conduct-Phase-3-Study-of-Ifenprodil-for-COVID-19.html
BTW
New, May 17, 2021 Guidelines from FDA. Options besides 'stand alone' CT are for 'umbrella' format or to join other sponsors etc, ie Drug cocktail/Big Pharma (Partnership?). I of course posted the link.
...GLTA...
The 'data' that McKie slammed was what Dr MW presented. " I see Sort of a Trend for some other stuff too"...
As we now see there has been better evaluations of Data done by the current CSO so that there is NOW a Real reason for an EOP2 FDA meeting to consider the beneficial results of Ifenprodil. ALI / COVID PF / Long-haulers with low O2? IL-6?
Discussions of Ifenprodil's possible uses for Cancers/Tumors was brought up by CM and MW but was not followed though, until now.
Next for Ifenprodil may be the data recently posted for Stroke. Maybe to complement the DMT Micro-dose concepts. We can Hope further research is being done...JMHO...
Outdated commentary of our MicroPharma/management and it's main CT drug seems the standard.
I'll speculate on the Positive possibilities. Investors can Buy/hold/trade/sell, but we Dont run the company...GLTA...
True, the 12-15 fiasco has been hard to shake for AGN.
But,
There are Four Significant Data P=values from the COVID CT to discuss about Ifenprodil during the EOP2 FDA Meeting.
Their IND filing said use for ANY impaired lung issue. Could there be some decision that will include a Phase 3 that encompasses ALI etc? That would be a 'marketable' event.
"The decision to file with the U.S. FDA, was made after a recent independent study found that Ifenprodil significantly reduced ALI and improved survivability in an animal study with Asian H5N1 infected mice by 40%. Asian H5N1 is the most lethal form of influenza known to date with an over 50% mortality rate. The drug was also previously shown in a separate study to prolong survival under anoxic (low oxygen) conditions, as might occur in patients with severely impaired lung function."
I would hope that AGN will claim, 'extenuating conditions' / COVID, for the delay / disruption / failure of the IPF/CC Trials in Aus/NZ and the Ifenpodil CT in S Korea. Then use this all as leverage/incentive for a minor redirection in the Phase 3 to focus on 'Lung Impairment'' Long Haulers too for the COVID associations. ALI/CC. Make the IPF just COVID PF. Possible.? IDK...
The existing / new FDA Guidelines were intended to add some flexibilities. JMHO...GLTA....
PFE seeking full approval for Vaccine and continues to submit data to FDA. Huge sales may finally mean a PPS raise?
NRXP valuation $1.5B/RLF $700M? Complicated Data analysis Presentation to FDA as .
JJ and Daniel own 60% of NRXP and with any approval get much more. THEY've been PAID, WTF do they care anymore. Hypocritic oath, health of Others? Greed/malfeasance/stupidity has dragged this out too long. Only a few have profited, common shareholders have been phukt and even Flipping/holding their Stocks for pennies/a buildout/more CTs for further indications, A REAL WORLD PARTNERSHIP with A BIG PHARMA Etc? Time has cost me/us Money.
Maybe an EMA application will get some Priority there. Finally some acknowledgement of patent holder RLF by NRXP but has the delay been overpowering?
JJ should have let the CT Run/Complete instead of HIS FUBARS with the FDA. We will see IF HE/THEY have earned respect from the FDA or just PO'ed them.
Decreasing Volume @ both *+*.
Time has cost me/us Money. Are they really competing still? Is there hope for the DPA with McMaster and the formulation for extended shelf life. Dry film or Inhaled?
https://www.investors.com/news/technology/pfizer-stock-buy-now/?src=A00220
JJ and son got paid with NRXP being valued at 2X RLF?. $1.5B vs $700M.? Between them (D + JJ) they have 60% of stock.?
Is EAU to be filed 'with-in the next mount'?. Waiting for inhaled Zyemini Trial?.
$30 PPS for NRXP?.
?"NeuroRX has developed two main treatments. The first, called Zyesami is designed to treat respiratory failure in the advanced and most difficult stages of Covid. The drug is in Phase III clinical trials and the company plans submitting it for US Food and Drug Administration (FDA) emergency approval before the trial is completed. The aim is to file for approval in about one month. Swiss company Relief Therapeutics, which has partnered NeurRX in developing the drug, is traded on the Swiss stock market with a market cap of about $700 million.
In a trial, the company was asked to show a reduction in mortality from coronavirus due to its drug but was unable to demonstrate this among a group of patients although it did succeed in reducing the number of days spent in hospital, and effectiveness in other parameters such as the number of days to recover. The company is now conducting a trial of the drug on less seriously ill patients.?"
Dr JJ... 31 May 2021 ?
https://iglob.es/?en1372702
Also on the NRx Home page is the 'Pipeline'...This must also have been recently updated. NRXP volume is still low but Maybe a strong PR 6-1. I dont think NRXP will see $40 again soon but a move toward the "Max offering $ from BRPAmay happen"
" NRx Research Pipeline
Our pipeline includes medicinal candidates in Phase 2, and Phase 3 trials for COVID-19-related Lung Injury and Acute Respiratory Distress (ARDS) in partnership with Relief Therapeutics, AG,"