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Post by goyocafe on Aug 10, 2021 20:57:30 GMT -5
Didn't mnkd have some sort of patent on VIP? Aviptadil is a patented form of VIP. This raises an interesting question. What makes Aviptadil unique? And what would prevent MNKD from developing their own VIP compound that does not infringe on Aviptadil and run with the development solo?
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Post by peppy on Aug 10, 2021 21:22:04 GMT -5
Didn't mnkd have some sort of patent on VIP? Aviptadil is a patented form of VIP. This raises an interesting question. What makes Aviptadil unique? And what would prevent MNKD from developing their own VIP compound that does not infringe on Aviptadil and run with the development solo? I looked. some of the proteins are difficult. See the L- alpha/a aspartl ? That looks like a holy molely. It doesn't look like mRNA which can be made in a bio reactor? The physician said yeast could be made to produce VIP, the fermenters.
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Post by peppy on Aug 10, 2021 21:40:23 GMT -5
Dr Jonathan Javitt of NeuroRx Pharma is a brain. He is trying to save the world. Look at what the man has figured out. 1. repurposing a drug, VIP was shown to block replication of the SARS-CoV-2 virus in human pulmonary epithelial cells and monocytes, while also demonstrating clinical improvement on radiographic and laboratory parameters.12 In addition to its antiviral effect, VIP protects the Alveolar Type II (ATII) cell by upregulating surfactant production, blockingapoptosis, and blocking cytokine effects.2. had only a few weeks of stability,3. August 9, 2021 Made more stableNRx Pharmaceuticals (NASDAQ: NRXP) has announced the validation of the first commercial ZYESAMI (aviptadil) formulation for intravenous use, permitting high volume production. NRx has increase aviptadil production Equally, the company has increased the production lot size of aviptadil by 30 to 50 times while lowering the cost of its peptide supply by 90%. As prospective regulatory clearances in various areas across the world are achieved, these two innovations position NRx to potentially administer millions of ZYESAMI doses. "Intervention: 3 successive 12-hour intravenous infusions of aviptadil at 50/100/150 pmol/kg/hr." 4. He wants to make it cheap for the WORLD. VIP can ultimately be produced at a cost of pennies per dose, if moved from chemical peptide synthesis to yeast fermentation, 5. Javitt, "I had the privilege of working closely with Dr. Alfred Mann
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Post by peppy on Aug 10, 2021 21:59:49 GMT -5
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Post by peppy on Aug 10, 2021 22:20:04 GMT -5
It is a dream I am typing about MNKD and Coronavirus. MNKD Saves the World. mango
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Post by oldfishtowner on Aug 11, 2021 15:21:46 GMT -5
Peppy, so do you think that Ackerman et al provided the loan?
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Post by peppy on Aug 11, 2021 15:29:16 GMT -5
I am wonder. Fauci is involved. Did the powers that be help make sure MNKD had some financing at a good rate in exchange for the possibility of a cheap worldwide therapeutic? I hope so. These men are brains.
NRXP was BARP? held by a holding company and became NRXP is that the story?
I am very political these days, I have the cable news on constantly. The Kavangh thingy-gthiny..... Questions about how his house was paid off. hahaha
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Post by peppy on Aug 16, 2021 14:41:17 GMT -5
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Post by peppy on Aug 17, 2021 6:42:37 GMT -5
finance.yahoo.com/news/nrx-pharmaceuticals-announces-2nd-quarter-013200895.html- Emergency Use Authorization (EUA) Request for ZYESAMI™ (aviptadil) Pending with United States Food and Drug Administration to Treat Patients Suffering from Critical COVID-19 with Respiratory Failure - Emergency Use Authorization Granted to ZYESAMI in Nation of Georgia to Treat Critical COVID-19 Patients in July; First Orders for ZYESAMI in Georgia Under Discussion - NRx Pharmaceuticals Initiating Phase 2b Trial in Georgia of the BriLife Vaccine for COVID, Developed in Conjunction with the Israeli Institute for Biological Research RADNOR, Pa., Aug. 16, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (Nasdaq: NRXP), a clinical stage biopharmaceutical company today provided a business update and financial results for the quarter ended June 30, 2021. NRx will host a conference call Tuesday, August 17, 2021, at 8:30AM Eastern Time to discuss its business update and second quarter financial results. "NRx is pleased to report its first quarterly results as a publicly-traded company. We have continued to make substantial progress as a company with the filing of an EUA request for ZYESAMI in the US on May 31st, and the filing and granting of an EUA in the Nation of Georgia, with first orders expected shortly. We are honored to have been selected by the Israeli Institute for Biological Research to develop and market the BriLife COVID vaccine. Finally, we are looking forward to restarting trials of our psychiatry drug, NRX-101, in the coming months," said Prof Jonathan Javitt, MD, MPH, CEO and Chairman of NRx. Business Highlights in Q2 Primary clinical activities during the quarter centered around analysis and regulatory filing of data from the phase 2b/3 trial of intravenous ZYESAMI™ for COVID-19 Respiratory Failure, support of the NIH-sponsored ACTIV3b Critical Care study of ZYESAMI compared to Veklury (remdesivir) alone and in combination, support of the BARDA-sponsored I-SPY trial of inhaled ZYESAMI, and the NRx-sponsored trial of inhaled ZYESAMI. On the manufacturing front, the Company focused on development of the first shelf-stable formulation of ZYESAMI, which was announced in early Q3, along with engagement in scaling up aviptadil drug substance from 100,000 doses per manufacturing batch to a projected 3 million doses per batch, combined with a 90% reduction in cost per gram of aviptadil drug substance. On the business development front, NRx engaged in successful collaborative negotiations with the Israeli Institute for Biological Research (IIBR) that resulted in the long-term partnership announced in Q3. The company entered into a collaborative agreement with TFF Pharmaceuticals to develop a dry powder reconstitutable form of ZYESAMI that has now demonstrated initial room temperature stability. This technology has now shown promise for the development of a dry powder version of the BriLife vaccine. Our enthusiasm for this development project is based on nonclinical data suggesting an effective neutralizing antibody response to the Delta and other COVID variants, together with the rapidity with which this vaccine technology can be modified to cover new variants as they emerge. The company further initiated business development interactions with MannKind Corporation to leverage the Technosphere® platform for future inhaled use of ZYESAMI.
On a commercial level, the Company finalized its logistics and drug distribution contract with Cardinal Health, Inc., and its drug launch and commercialization support agreement with IQVIA, Inc. During Q2, NRx began its engagement with Georgia, Ukraine, and other countries around Emergency Use of ZYESAMI and potential clinical trials of the BriLife vaccine.
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Post by peppy on Aug 17, 2021 9:23:30 GMT -5
I listened to the NRXP conference call. Aviptadil does not have FDA approval. Zyesami is NRXP novel form of Aviptadil.
MNKD was mentioned a couple times by Dr. Javitt during the CC. MNKD will allow another patent on the product.
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Post by goyocafe on Aug 17, 2021 13:20:26 GMT -5
Didn't mnkd have some sort of patent on VIP? Aviptadil is a patented form of VIP. This raises an interesting question. What makes Aviptadil unique? And what would prevent MNKD from developing their own VIP compound that does not infringe on Aviptadil and run with the development solo? Don’t hate me for quoting myself, but if I heard Dr. Javitt correctly today, Aviptadil is not patentable, but the process by which it is produced is. He went as far as to indicate that a powdered version of Aviptadil would be patentable due to its processing and end product characteristics. If this is the case, it would seem that Techno-VIP would have as much value as a patentable drug as Aviptadil does in its current form. What royalty should be expected if MNKD can actually make this stuff? Wouldn’t MNKD file the patent for it since it is Technosphere that is making Aviptadil unique? And then why would MNKD need to include anyone else in the development of the drug if they have all the IP and patent(s)?
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Post by peppy on Aug 17, 2021 13:31:27 GMT -5
I don't know. However this was interesting. I am putting it up so we can see the price pop. -- Company to Pursue Prophylactic Treatment Against SARS and Influenza for Daily Use as an OTC Product -- BERWYN, Pa., August 17, 2021--(BUSINESS WIRE)--Virpax® Pharmaceuticals, Inc. ("Virpax" or the "Company") (NASDAQ:VRPX), a company specializing in developing product candidates for pain management, CNS and anti-viral indications, today announced that it has received a written pre-investigational new drug (pre-IND) response from the U.S. Food and Drug Administration (FDA) for MMS019, its patented and proprietary high-density molecular masking spray under development for use as an anti-viral barrier product. Virpax believes the results of the pre-IND response support further research on MMS019 as an intranasal protective that may limit transmission of the viruses to others. Virpax expects to move forward and pursue a New Drug Application (NDA) for MMS019 as a once daily intranasal treatment. The FDA has indicated that Virpax may pursue an NDA drug approval with the Office of Non-Prescription Drugs. 222% price pop today. goyocafe , thank you for listening to the CC again and clarifying. look at the price action from the top in July until it popped. Does it remind you of the candles on MNKD chart? vaguely?
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Post by goyocafe on Aug 17, 2021 14:18:50 GMT -5
peppy , Are you looking at the correct company. I was comparing MNKD to NRXP, not VRPX. Although, I wouldn’t mind if MNKD followed in Virpax’s footprints.
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Post by akemp3000 on Aug 17, 2021 14:23:00 GMT -5
I like it Peppy. Our day is coming and sooner rather than later...finally
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Post by peppy on Aug 17, 2021 14:53:26 GMT -5
peppy , Are you looking at the correct company. I was comparing MNKD to NRXP, not VRPX. Although, I wouldn’t mind if MNKD followed in Virpax’s footprints. yes, I should not have answered on that post. I got a glimpse of VRPX and wondered what was up. since it is an inhaled therapeutic that popped, I talked about it on this thread, bad peppy. However, this is the way I am. I am looking for MNKD to gap up like VRPX when some news comes out. Did I say GAP up? ( Look for VRPX to continue; initiation gap, continuation gap, exhaustion gap.)
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