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Thanks for your intelligent post! (Happens rarely here.)
You forgot that Relief has registered the name Aviptacare under its subsidiary Relief Therapeutics International. It is possible that Relief in Europe/RoW will use this name for the brand launch. (Or it's just a backup in case JJ refuses to let Relief use Zyesami in Europe/RoW later).
Relief currently mostly uses RLF-100 or Aviptadil because it has not yet filed for approvals in Europe itself. Once that becomes more concrete, they may look into filing it under Zyesami or under Aviptacare. And until then, they're holding off on those names.
https://www.swissreg.ch/srclient/faces/jsp/trademark/sr300.jsp?language=en§ion=tm&id=01181%2F2021
Which is prerecorded from 8th/9th march. So don't expect too much, as the (good) 60 days results were not known/published at that time.
But for me it's very important to listen again to Ram, as he was very quiet in the last time.
For me the link is still working.
You also can go to the main page: https://fnih.org/what-we-do/programs/activ-partnership
And then click on the ACTIV-3B clinical trial protocol link.
Page 5 "Duration":
Participants will be followed for 90 days following randomization for the primary endpoint and most secondary endpoints. Selected secondary endpoints will be measured at 180 days.
I guess, it's not started yet.
The document (Study Master Protocol version 1.0) is written only 3 weeks ago, so I think it takes some additional time to recruit the first patients.
But this study has the gov and other organizations in the back and not a a tiny, unknown company like NeuroRx. So chances are much higher, that this study will be driven faster.
This is really huge and important for us!
With this new study (and hopefully same good or better results) we would have a total of 836 study patients (196 "our" study and 640 this study). This then much higher number of patients could be crucial for NDA!
NIH funded international multicenter phase III study with 640 patients between Remdesevir and Aviptadil!
https://fnih.org/sites/default/files/final/pdf/ACTIV-3b-TESICO-v1.0-15March2021.pdf
I got an answer from Relief IR in january:
Dear Mr. xxxx,
Thank you for your email.
According to Dr. Jonathan Javitt, there are some who believe that “ZYE” has African origins and means “stand by me.”
I hope this helps.
Kind regards,
Brittney Sojeva
I also sent them two (different) mails in the past and got answer in about 24h. But I guess, it depends on the questions you have.
This is a NeuroRx call only, so for an acquisition the patent holder (Relief) should be involved.
BP would not buy NeuroRx, they would buy Relief for the patent.
Lots of questions. I guess, the PR will be released in prior of this call. How else could you ask questions if you don't know the subject in advance?
I expect the dial number mentioned in the PR or they update their homepage before this.
LOL You made my day!
aviptacare.net domain was registered 01/12/21
it seems aviptacare.com/.ch/.org are also registered.
btw, I don't see any terms for inhaled only..-
Hopefully we will see you never again here.
There was a time, where this board was really interesting. Discussions and DD and no vanilla BS caps...
I guess, I'll also stop writing here...
Did I miss a discussion about this remarkable text from the latest BRPA Merger Report?
The DMC determined no safety concern or basis for stopping the trial on the grounds of safety. Similarly, the DMC determined no basis for stopping the trial on grounds of futility and cleared the trial to full enrollment of 195 patients. Top line data are expected in the first quarter of 2021.
A second administratively assigned study aviptadil vs standard of care in 45 patients conducted under an Expanded Access Protocol (NCT04453839) has demonstrated 9-fold improvement in survival and recovery from respiratory failure in highly comorbid patients (P<0.001).
The RCT’s Data Monitoring Committee released clinical results of the first 21 patients to OWS for unblinded review. At the request of OWS, these data have been combined with 21 aviptadil-treated patients and 24 concurrent standard of care controls. A dramatic effect on both survival and recovery from respiratory failure was documented in the combined data set of 31 aviptadil-treated vs 35 control patients (Figure 5). Additionally, a 2.8-point difference in NIAID ordinal scale (P<0.0001) and a 112-point difference in PaO2:FiO2 blood oxygenation index (P<0.0001) difference was demonstrated. All underlying data and SAS programming code were shared with OWS for detailed examination and verification. The improvement in recovery from respiratory failure and in survival was preceded in many cases by clear radiographic improvement. In the 21 aviptadil-treated patients from the Houston Methodist study, clear bilateral improvement was noted in 17 patients and unilateral improvement was documented in 2 patients (Figure 5).
sorry, didn't know the LinkedIn comments are only accessable for members.
Will post a screenshot tomorrow.
Gilles della Corte (Chief Medical Officer Relief) on LinkedIn about 1 hour ago: "Topline data expected in the coming days for the US trial. Best regards"
https://www.linkedin.com/posts/gillesdellacorte_excess-mortality-in-2020-especially-high-activity-6760184788763635712-5Fml/
Thanks.
Maybe a correction of this finding:
It seems as Herculis holds these shares since 1 year already! It just was not listed on marketscreener until today.
This does not mean, that Herculis has bought this in the last days!
Look at here (date of Herculis entry): https://markets.ft.com/data/equities/tearsheet/profile?s=RLF:SWX
I don't know, what's really current. But don't trust just one page alone.
Because I saw a screenshot from this page from 10/01/21 and Herculis was not listed. So we can assume, that they bought between 10th and now.
(Sorry, no link for this screenshot)
Here's another interesting link: https://www.morningstar.com/stocks/pinx/rlftf/ownership (it seems it will be updated monthly, so Herculis is still missing on this list. We should check this again end of january)
Herculis Partners SA bought 33 mio shares in the last days, which equals to 1.02% from the float.
https://www.marketscreener.com/quote/stock/RELIEF-THERAPEUTICS-HOLDI-5527488/company/
Sorry, I read your first sentence "Not sure if this was posted already." wrong. I thought you want to know, if RLF-100 was already listed there in the past.
I know it was updated now. (Unknown reason...maybe new name)
It's there since at least 26 June 2020
https://web.archive.org/web/20200701021908/https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-therapeutics-tracker
Maybe updated due the new trade name (Zyesami)
If you're really invested or interested in Relief, you should know their homepage.
And there you find the following text (FAQ):
How long will it take the FDA to approve RLF-100™ after top-line data are available?
Assuming that the top-line are positive, the FDA could at that time consider granting EUA, which would permit the drug to be launched in Q1 2021. A New Drug Application (NDA) submission requesting marketing approval would be filed based on positive top-line results. Full NDA approval could be granted to RLF-100 for the US market by Q3 2021. The FDA granted RLF-100™ fast track designation, which, among other things, makes RLF-100™ eligible for Priority Review if relevant criteria are met. Priority Review designation means the FDA’s goal is to take action on an application within 6 months compared to 10 months under standard review. It would be reasonable to expect Priority Review for applications filed under the Coronavirus Treatment Acceleration Program (CTAP). RLF-100TM is part of this program, which was promulgated by the FDA earlier this year in express response to the emergence of the COVID-19 pandemic.
Again a notice of delisting to BRPA:
As previously reported, on November 23, 2020, Big Rock Partners Acquisition Corp. (the “Company”) received notice from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) stating that, as of November 20, 2020, the Company was not in compliance with Nasdaq Listing Rule IM-5101-2 (the “Rule”), which requires a special purpose acquisition company to complete one or more business combinations within 36 months of the effectiveness of the registration statement filed in connection with its initial public offering. Since the Company’s registration statement became effective on November 20, 2017, it was required to complete an initial business combination by no later than November 20, 2020, and was therefore subject to delisting unless the Company timely requested a hearing before the Nasdaq Hearings Panel (the “Panel”). The Company timely requested a hearing, which stayed any further delisting action by the Staff.
On January 4, 2021, the Company received a second notice from the Staff stating that the Company’s failure to hold an annual shareholder meeting for fiscal 2019 by December 31, 2020, as required by Nasdaq Listing Rule 5820, could serve as an additional basis for delisting. At the hearing, the Company will address both issues by presenting its plan to complete the previously announced proposed merger with NeuroRx, Inc. and thereby evidence compliance with all applicable criteria for initial listing on The Nasdaq Capital Market and request an extension of time to do so. The merger agreement previously filed, indicates among other requirements that there will be an election of the directors as part of the shareholder meeting to vote on the merger.
Although the Company is working with all due haste to complete the merger, there can be no assurance that the Panel will grant the Company’s request for continued listing pending the merger’s completion or that the Company will be able to complete the merger within the period of time that may be granted by the Panel. The Panel has the authority to grant the Company an extension through no later than May 24, 2021.
You missed the most recent one:
The did both an echocardiogram and a CT Scan on her lungs. Heart looked good and the lungs looked amazing compared to how they looked a month ago. The right looked like a whole lung and about 70% of the top of the left was recognizable as a lung even to me.
Since Aviptadil has had such a pronounced effect on Delinda’s lungs, Dr. Youssef is in the process of asking the FDA for permission to administer it again in hopes of more improvement.
It is the same text as months before. It was discussed forever in ALL forums at that time.
So stop with your stupid questions. If you are really interested, read these old texts. But you are obviously too lazy, otherwise you would have known all this already. (So much for your DD.)
Trademark is NOT patent! The 100% patent owner of RLF-100 is still Relief Therapeutics.
If you read top of the linkedin job listing, you will get the answer of this second SPA study:
The company has two lead clinical programs:
Aviptadil (RLF-100) - awarded FAST TRACK designation by FDA: In Phase 2/3 for Critical COVID-19 in the USA
NRX-101 with Breakthrough Therapy Designaion, SPA. Currently in P2b/3 clinical program for the Treatment of Severe Bipolar Depression in Patients with Acute Suicidal Ideation and Behavior (ASIB).
Our P2/3 Aviptadil study (144 patients) could lead to an Emergency Use Authorization. This study is in a critical phase, and your participation will be essential. An aditional study(ies) in earlier patient populations, with an inhaled form is in the planning stage.
Our P2b/3 SPA study of ~150 patients is the only study required for approval for our first indication. Therefore this role requires an experienced "hands on" clinical operations professional that is excited about working at all levels.
c'mon...just read the date:
"Last Update Posted : September 29, 2020"
So, looks not really current...
OMG...is it really soo difficult?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=160312370
You should first know the difference between Sweden and Switzerland.
Relief is a SWISS company: S-W-I-S-S and not Swedish.
Here's the text:
Prof. Javitt will be interviewed by Dana Weiss on the topic of:
VIP: How the Legacy of One Coptic Doctor from Egypt May Help Save Humanity from COVID
STAY TUNED
for our Post Conference Satellite Interview with Prof Jonathan C. Javitt
John Hopkins University, Baltimore, MD, USA
Nice interview with Dr. Javitt.
it seems strange that RLF is not publishing more aggressively especially since NIH is fishing for studies (unless data are unvconvincing..uggh)
Here a DeepL translation of today's printed article of the swiss "Finanz und Woche" newspaper. (dated 7th november 20)
Note: "Finanz und Woche" (FuW) is considered critical or even negative towards Relief.
Relief recovering after positive report
The biotech company can continue its corona study after an interim analysis. It is refusing a recommendation to sell its shares.
The committee, which is monitoring the execution of the study with the active substance RLF-100, has given the green light for the continuation of the corona development project. This was announced by Relief Therapeutics on Thursday.
The Data Monitoring Committee evaluated data from 102 randomly selected patients observed for at least 28 days and concluded that the study with the potential drug from the Geneva-based company has a good chance of success. The decision of the seven scientists on the committee was unanimous. Relief has thus survived the second interim analysis.
A first one with the data of thirty patients had shown a positive data trend. Otherwise, the committee would have demanded the discontinuation of the study. Relief's shares rose by around 50% on Thursday and Friday.
Uncertainty remains
They are still 20% lower than at the beginning of the week. The stocks were under pressure on Tuesday and Wednesday. The trigger was probably an article in "Finanz und Wirtschaft". This mentioned, among other things, a sell recommendation by Olav Zilian, a pharmaceutical analyst at Mirabaud Securities, from the previous day. The recommendation was triggered by the study stop for a possible competitor product that Zilian considers similar. Relief Chairman Ram Selvaraju contradicts: "The molecules of the two companies had a different mechanism of action (see box on controversy).
Relief's share price is based on the hope that the anti-inflammatory RLF-100 can help seriously ill corona patients. If the ongoing Phase IIb/III study does not show efficacy, the share price is likely to plummet. The results are now expected in January.
The fact that the share price has not rebounded to its previous level may also be due to the fact that investors had expected more from the decision of the Monitoring Committee. With exceptionally good data, it would have recommended the early termination of the study. The partner company NeuroRx already submitted an application for emergency approval in the USA at the end of September. A very likely positive decision by the US Food and Drug Administration (FDA) in a few days would have been realistic. Now the waiting continues. It remains uncertain how well RLF-100 actually works.
Details of the interim analysis will not be published. Only the members of the monitoring committee saw them. The unanimous decision to continue the study shows that obviously nobody seriously doubted the success of the study - the proof of efficacy with acceptable side effects. RLF-100 apparently showed a data trend in the second interim analysis, which could range from rather weak to very good, but not outstanding. If the signal was weak, it is possible that the compound may ultimately fail to reach statistical significance.
Secondary goals also count
Approval would also be conceivable in this case. RLF-100 could also achieve individual secondary goals such as accelerated recovery, shortening the duration of artificial respiration or improving the oxygen content of the blood. Gilead's Remdesivir has received emergency approval after showing faster recovery.
The interim result of the Phase IIb/III study suggests that relief is unlikely to be a miracle cure, but it may help seriously ill patients. That would be progress. The chances of commercial success may have been somewhat diminished on Thursday, but they remain intact. The shares of Relief Therapeutics remain risky. An engagement is reserved for players.
Chairman of the Board of Directors Selvaraju and bank analyst Zilian in duel
Following the stock crash, Olav Zilian, the analyst from Mirabaud Securities, who most likely triggered it with a sell recommendation, and Ram Selvaraju, Chairman of the Board of Directors of Relief, engaged in controversy.
The trigger for the sell recommendation was the study stop due to the hopelessness of PhaseBio's pemziviptadil. Zilian considers it to be very similar to Relief's RLF-100, while Selvaraju, himself a pharmaceutical analyst and Managing Director at broker H. C. Wainwright, points out crucial differences, especially the mechanism of action.
The focus is on the relevant receptors on the cells, VPAC1 and VPAC2. According to PhaseBio, the active ingredient pemziviptadil docks selectively to the VPAC2 receptor. RLF-100, however, binds rather strongly to both receptors. Relief's hypothesis is that the ability to bind a VIP-analog molecule to VPAC1 is crucial for influencing the course of disease in Covid-19 or other patients with respiratory problems. VIP means vasointestinal peptide. VPAC1 is important because these receptors are expressed on type 2 pneumocytes. These play a critical role in Covid-19.
Zilian, however, doubts that the two peptide chains are actually different. RLF-100 corresponds to naturally occurring VIP, and PhaseBio calls its pemziviptadil a fusion molecule between natural human VIP and a molecule that extends its half-life. In addition, RLF-100 binds to both receptors quite strongly, and PhaseBio does not refer to any data on its website to support its claim. It is not known to what extent the PhaseBio compound binds primarily to VPAC2.
Selvaraju also points out that RLF-100 may affect several processes. For example, there is evidence of an antiviral effect of RLF-100, and it could also protect the aforementioned type 2 pneumocytes in the lungs. This may even be crucial for the VRP. This is because these cells produce a mucus that is essential for oxygen exchange. The Chairman emphasizes that the relief compound has passed both the first and second interim analysis of the Phase IIb/III study without any problems. PhaseBio did not even pass the first one.
However, Zilian believes that the ongoing Phase llb/III study would have been stopped if it had generated very convincing results. He also assumes that the increase in the targeted number of patients from 144 to 165 is an indication of an initially less pronounced data trend. Selvaraju replied that the early termination of the study was a hurdle that was extremely difficult to overcome. The increase in the number of study participants had been encouraged by the U.S. Food and Drug Administration (FDA) even before the first interim analysis.
Written by RUPEN BOYADJIAN
Great! Now we can ask ANYTHING to Dr. Javitt and get REAL answers!
IHUB will be the number one board for Relief insiders...
I think this BARDA PDF title in the metadata is misleading. Javitt is using Microsoft Word for Office 365 to create these PDFs. So maybe in one of his Word documents there was this old title in the Metadata and he forgot to delete or change it. All of these Word metadata will also be written to the PDF metadata when creating a PDF. (But you don't see it in the document itself.)
I will forget this title. (It's only a hint, that Javitt had some Word documents in the past with this title in there )
Did you see the PDF TITLE (not filename) when downloading the PDF? (this is not the title inside the text)
"BARDA Broad Agency Announcement BAA-18-100-SOL-00003 Amendment 13"
And PDF creation date is 12th august.
The version from two days ago had a PDF title with "VIP in the treatment of Critical COVID-19" and PDF creation date 26th october.
These are indeed complete different papers.