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This was an interesting read on new COO at his former company.
Best
Dave
https://www.bizjournals.com/austin/news/2020/09/11/savaras-top-two-executives-resigned-on-friday-ef.html
Hi Nels....always appreciated your posts in the past. You obviously don't like the recent trial results and curious how you reconcile Zyesami's invitation in the large NIH trial with Remdesivir. Why would they bother to continue investigating the use of the drug if the results were so poor.
Also, curious about your thoughts with Relief growing portfolio of products (APR and Advita).
Appreciate your thoughts.
Take care.
Dave
That is pretty powerful. Thanks again for sharing mc67.
Dave
Thanks for sharing mc67. I read this on the Yahoo board earlier this morning. I like the "Relief is actively and constructively striving to find an amicable solution to the resolve the dispute". That definitely tells me there is a communication breakdown and also some issue with patents and/or allocation of profits.
I believe they will work it out under a win-win. It could simply be Neuro is overwhelmed with all the workload and they haven't provided all the necessary documents for reimburse. However, my gut tells me this is more about profit sharing arrangement. If correct, this is a positive because Neuro feels like they have something special in their formulation.
Time will tell. Good luck to all...even the negative rehashers.
Dave
Based on Neuro pr, we are getting scientic report. Sounds like tonight.
From the pr:
"The first scientific report of 60-day data from the phase 2b/3 trial is expected to be released imminently."
Every little bit helps :)
Nice interview with Javitt on Cheddar out on LinkedIn today. Have a great weekend everyone.
Dave
Javitt Cheddar Interview
That was weird. I had the link in original post. Included it below.
Dave
Pfizer begins early stage clinical trial testing oral antiviral drug for Covid
https://www.cnbc.com/2021/03/23/covid-pfizer-begins-early-stage-clinical-trial-testing-oral-antiviral-drug.html?__source=androidappshare
Per Pfizer Chief Science Officer today: "“Tackling the COVID-19 pandemic requires both prevention via vaccine and targeted treatment for those who contract the virus,” Pfizer’s chief scientific officer, Mikael Dolsten, said in a press release. “Given the way that SARS-CoV-2 is mutating and the continued global impact of COVID-19, it appears likely that it will be critical to have access to therapeutic options both now and beyond the pandemic.”
Link to CNBC Pfizer article
Hey Ratna...sent you a private message with a question.
Take care.
Dave
Inelgr,
Is it possible that any of the trial sites no longer listed for inhaler could have transitioned over to the I-SPY initiative? Just thinking out loud with the changes in sites.
I work for a large hospital network and know many hospitals are suffering with staffing shortages. Our hospital is more pediatric focused so don't see as many Covid cases. However, we did encounter financial challenges and laid off about 10% of staff by the end of 2020.
Thanks,
Dave
Vanilla,
The kqed.org radio network serves northern california and quite a few people.
https://www.kqed.org/about
Did you notice that the radio player is sponsored by Stanford continuing studies. Don't we have an inhaled trial at Stanford?
Sounds like some good media is you ask me.
Dave
Thanks Choo Choo. I must have misunderstood.
Take care.
Dave
Private message board....I believe someone in this forum said their was a private message board on RLFTF that was free of some of the posters here. Can someone private message me the location if accepting members.
Thank you.
Dave
Thanks for sharing dmsrz8. The last page of the report says "This research report has been commissioned by RELIEF THERAPEUTICS Holding AG". Is is common for companies to do this?
Thanks,
Dave
You saying this could be "bad" news....say it isn't so. You are always so positive so I'm really concerned. NOT
We are all waiting with baited breath for you big "BUT" or "HOWEVER" statement Vanilla.....when is it coming? We are waiting. Don't forget to look at that script for next steps.
Lol
Looking forward to release of blinded trial data. Article out today states that the South African variant of Covid could cause issues for antibody therapies.
I wish Dr. Scott Gottlieb wouldn't use words like "obviate". He could have said it would inhibit. Sheesh...so complicated.
https://www.cnbc.com/2021/01/05/south-africa-covid-variant-appears-to-obviate-antibody-drugs-dr-scott-gottlieb-says.html
Hey Jrock....hard to sell shares in a company that you don't own. More than likely compensation comes from being a paid basher, not a stock holder.
Ask yourself, why would they stay if they hate the stock so much?
Glad to have you onboard.
Dave
Vanilla obviously has other motives as no person would take this amount of time to post on these boards screaming about the supposed FDA injustice to a bunch of investors. We have no control over what the company does or how this trial unfolds. Feel free to bombard someone else. I've muted several that post like this.
Going back into my quiet holding mode and seeing how this stock unfolds.
All the best to longs.
Dave
Thank you oodtw and Bartsdad. Appreciate the translation.
Dave
Anybody able to translate this? Dead end for me.
Dave
Thanks for sharing the video and your thoughts. Fun to watch. On a side note, you both would be fun to party with : )
Dave
I laughed when she asked the results question because Javitt had just given the presentation and provided some results on open label. Hate to be judgmental but that moderator didn't know what planet she was on and was probably focused on dinner plans for the night. I caught myself role playing what a true moderator would do, demonstrate interest and ask some of the obvious questions like "why the hell isn't this drug already approved". Oh well....
Dave
Unfortunately, I didn't find the meeting moderator very interested or educated to ask Dr. Javitt questions. I really wanted someone to ask Javitt why the drug wasn't more widely known or discussed via main stream news considering the positive results to date.
However, Javitt did a good job in his presentation today.
Dave
Sorry...link to the article with the doctors statement is here.
Thanks,
Dave
https://nptelegraph.com/news/local/watch-now-great-plains-health-only-hospital-in-nebraska-helping-test-covid-19-drug/article_db0bb030-25f8-11eb-bfb3-73b7242b5df1.html#tracking-source=home-top-story
In the recent news article on Aviptadil in Nebraska hospital, the infectious disease doctor, Dr. Eduardo Freitas, "emphasized that aviptadil isn’t a silver bullet and that studies are needed before the medication can be used widely to treat COVID-19.".
I'm curious what everyone thinks about this statement. The NBC video about the same patient seemed very optimistic. I wonder if the doctor made that statement because of the patient population (severe to critical) and that the disease creates other problems for the patients. If Aviptadil is used earlier in the disease onset (i.e. when a patient presents at the hospital), maybe the doctor would think differently if the disease is not allowed to damage other parts of the body.
Just thinking out loud.
Thoughts?
Dave
Aviptadil at a Tampa Bay area hospital
A buddy of mine is a Pharmacist at a large, Tampa Bay area hospital network. He texted me yesterday a picture of a small container labeled with "Aviptadil/Vasoactive Intestinal Polypeptide). They just started using for investigational use. No high use yet.
At least I know where to go if I get a bad case of Covid : )
Take care.
Dave
r_deckard...thank you for sharing the full article. I found the last sentence very interesting, especially the part bolded:
"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.
It seems like the analyst, Olav, wasn't able to fully appreciate Relief's drug and how it impacts both VPAC 1 & 2. Also, this same analyst isn't convinced the 2nd interim analysis was as effective as the first and thus the basis for his article. I liked how Ram stated the FDA wanted the increased number of patients in the trial and this was known before the first interim analysis was even done. That is reassuring.
At the end of the day, it doesn't sound like this drug is a stinker. So now we wait to see if it helps a little or a lot for critical patients. It will be amazing if the impacts are even bigger on healthier patients just presenting with Covid.
Have a nice weekend all.
Dave
Thanks for sharing article mc67. That news is pretty powerful and looks perfectly suited for RLF. I think the true power to our drug is getting to patients very early in the process and thus the inhaled version is what truly intrigues me.
Take care.
Dave
Thanks Randy. So if trial isn't stopped, individuals/hospital wanting to get the drug will need to go through the extra hurdles (mainly internal to the hospital) until this is approved. Is that correct?
I wonder if the results for the first 50 patients showed complete recovery, zero safety concerns, peoples ages improved by 20 years and even helped the bald guys grow a thick head of hair, would the FDA ever approve early or is it a matter of process that they need to wait for the full trial results?
I don't invest in a lot of biotechs so just trying to understand if anyone has experience with the FDA approving a drug super early in the trial process because the results were incredible.
Thanks,
Dave
One more follow-on point....I'm not asking the question because of concerns to sell. I'm asking to understand the process.
I'm a bigger believer in getting VIP to patients earlier in their onset of covid disease. Also, I see the big picture for all the other diseases the company plans to target.
All the best.
Dave
Need some help from smarter people than me.
I'm trying to better understand the mechanics of the blinded study. Based on today's news announcement of no futility or safety concerns and company's plan to continue to 165 patients, what does that indicate:
1. If the company continues on the journey to 165 patients, can the FDA still stop the study early and get this drug to all hospitals BEFORE the readout of top line results in Jan?
2. If the answer is "No" to #1 above, does that indicate this drug may only be "good" and not great for this critical covid patient population?
I'm in for a sizeable position and didn't sell any shares during the sell-off...in fact, but a few more. I like the quality of people involved with the company and all the breadcrumbs along the way.
Appreciate any thoughts from the smarter people : )
Thanks,
Dave
I noticed that too. Was wondering if Politico hit article made them rethink the board with more medical experts.
Saw that but would have expected bigger drop if all selling. Hmmnnn
I found these two items in the paragraph to be very powerful in the new revised document:
"While VIP clearly prevents cytokine storm as shown below, its primary effect is to block viral replication in the first place
and to upregulate the production of surfactant that is critical to blood oxygenation. Hence, VIP represents the first COVID-19 therapeutic to
directly combat the replication of the SARS-CoV-2 virus at the site of injury."
Best.
Dave
So the question now is....did someone just make a mistake on which program Relief has been selected for inclusion as that looks to be the only change from the two versions.
At the end of the day, sounds like the same result and still more positives for the company weekly.
All the best.
Dave
Nelskof,
The youtube video that Tigger posted today also seems to reveal more info regarding the DSMB meetings. Not sure if you listed to that yet. I fast forwarded through the explanation of RLF-100 and to the mid-way mark which got more into "what next".
Give it a listen if you already haven't. Would appreciate your thoughts to see if it matches up to what you typed earlier.
Thanks,
Dave
Thanks for sharing Tigger. The moderator was same person facilitating some of the SACHs European sessions several weeks back. This looks like a recent video...posted yesterday.
Dave