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Fung has made over 113k post and moderates like 15 boards on here. He’s a paid shill nothing more. No one not getting paid has time for that!
I’m in the camp that we have to run a trial before applying for approval. It’s frustrating, but that’s the FDA for ya. I’m am encouraged that we’ll use our selection criteria “algorithm” and it appears that early response rate may be used as an endpoint. Which would mean once enrolled we should get the needed data in 6 to 8 weeks per patient. Also, I’m hoping that the previous trial will peak the interest of major cancer centers to participate and enroll quick once initiated.
For me, just fine. I see that Napoleon complex is still going strong.
Cheers!
Lol! Buddy, you really need a hobby!
It’s nice to see some of the long time posters back! Sab, Park, Lightrock, and others. It’s good to see you guys posting again. Hope things are going well for y’all. I just re-entered in the low 3’s. If you’ve taken a position too, wish us the best of luck!
It's been very interesting reading the back and forth concerning the dropouts and the high risk group's possible os %'s. Quick thought, would appreciate any comments on it (even if you call me a moron). Since risk assessments are done after surgery, would it be possible that mk moved poeple out of the high risk category? I know it would of probably been included in the pr if known, but if we have an abnormally high patient count in the low risk group it could be a tell. Hopefully we get some additional info tomorrow.
GLTA!
I assume OWS = Operation Warp Speed.
That's a great question. I've often wondered what raw data was turned over to the statistical firm hired last year. Geert said numerous times they know more than us. He seemed rather confident during the presentation of their soc % projections. I believe later in the presentation he said, If I told you what they returned to us you wouldn't believe it.
I always thought we'd get government funding once approved for covid. However, do to the recent investor deal I believe FDA is going to require more enrollment for cd12 and phase 3 for cd10. Having said that, what are the chances that we may also need the money to start production for Mexico?
You aren't kidding about cydy. Hit piece, fake lawsuit, major selling pressure with volume 6 times the average.
Low of day didn't come close to my average, but can't say I wasn't slightly nervous. We'll find out if it's the real deal in a few weeks.
Following up on the moa of leronlimab. Below is a video giving a detailed description. It's long but interesting.
https://www.beckman.com/resources/videos/symposiums/covid-symposium-day-3-session-3-bruce-patterson
Full disclosure I haven't watched it all, the littles are running wild.
Lightrock, Thanks for the clarification. In that case, I'm gonna have to rewatch the video too.
Thanks again.
Yes, it does have an antiviral effect, drops viral load to 0 by day 14. According to Dr. Patterson. Basically it rebalances the immune system, stops the cytokine storm, and reduces viral load. Possible one stop shop.
@lightrock, I had my reservations about it too, but figured a small amount wouldn't hurt. I'm gonna continue to watch and may increase my position if July data is promising.
Thanks and good luck!
No problem Mogles. Results for both trials, moderate and severe (severe is an interim), are due in July. Might just get a double whammy (CVM/CYDY) next month! Another thing to note, really interesting when he speaks on cancer and how the best tool to fight it is the immune system.
Because I like you guys. I'm gonna put this little link below:
https://vimeo.com/429981545/2e3dece884
This is todays TEDx, go to minute 9 and watch Dr.Bruce Patterson talk about covid and Cytodyn's leronlimab.
Oh, and go CVM!
@Sab, we may not of had much of a dialog on the board, but I appreciate your insight. I'll be praying for your family. Hope to hear that your daughter makes a full recovery soon.
Charmed, Q, Kap, and many others I share your frustration. Full disclosure I signed in as a guest. That's on me. However, I thought more would be touched on in general, without the need for inquiry:
Manufacturing update scheduled completion?, have they reached out to FDA for guidences?, upgraded capacity?,etc.
Some comments on the possibility on an IDMC meeting besides "we won't discuss".
Hell, what are the objectives of hiring the lobbying firm, & is it bearing any fruit?
Instead he seemed unenthusiastic for nearly being "nose to nose" for 298 and not forthcoming.
In contrast, I attended another webinar for a company of similar size. It was live q&a for 45 minutes with the CEO, CSO, and a VP all very engaged. Completely open forum shareholder or not. It would be nice if cvm would open up like that.
From the lastest article about UGA's Dr. Ross efforts.
"Scientists in his lab have already begun analyzing the viral genome to find the right targets that will prompt the immune system to create protective antibodies, and they will examine how effective those targets are in small-scale lab tests soon."
https://news.uga.edu/uga-researchers-developing-coronavirus-vaccine/
Just some info on UGA's Dr. Ross and his ongoing work.
https://news.uga.edu/nih-awards-130-million-flu-vaccine-development/
Solid point, but they could of easily said just March or April. Just the specificity of that date strikes my as odd. Makes me wonder if the October idmc meeting was our last. Fingers crossed.
The specific date makes me wonder if lobbying has paid off. Just random thoughts.
Sorry meant that as a general statement, not reply.
I understand people's sentiment that the CT site update is just another move of the marker, but isn't it the first time they included a day? Seems different & specific to me.
Here's my little thesis, admittedly I could be way off base.
298 has happen and being verified this month. This info was hinted at the JPM hence increased volume and sp. Still a risky play until data so we didn't skyrocket in volume. Believe they are working on the data and just before or after the conference comes the news.
Why I believe this:
-No update on the trail site.
-The Incentive plan shows 23.5k remaining for issuing out of 640k reserved. Thats roughly 4%, what was Ergomeds leak? This plan was adjusted for rs and dilution. The triggers can't be sp (too high), must be events. Awards are in 25% intervals (160k) per. Last two trigger events were completion of study and filing of BLA.
Just my thesis. Could be way off.
Lol.. I can't tell if you're making fun of my assumption or you agree.
Biobonic, you'll have to forgive me I'm beyond my scope. Quick question about the 2014 incentive plan.
Page 13 of the 2020 s8 states the the shares reserved 640k and the shares issued 616.5k as of 12-31-19. Also states only a remainder of 23.5k for issue. Wouldn't this imply we are beyond incentive 3 (completion of the study) as of 12-31-19?
Thanks!
Lol. Haven't went on the boards this morning. Put my order in for 550 @ 7.20. Then started thumbing through the boards and it appears we are making a stand. Lock arms boys and girls, wish I could do more!
I totally agree that dropouts are one of the unknown factors that could sway results one way or another. That being said, I do believe they will be contained to a reasonable %. By reasonable I'd say =/< 15%, exlcuding the Inventiv enrollment (uncertain). After speaking to someone in the medical field that has had experience with individuals treated for HNC, these are some things to consider.
1. Pain management pre & post treatment
2. Nutritional plan (meal prep or feeding tubes)
3. Reconstructive surgery
4. Physical therapy (swallowing, speech, etc.)
5. Routine follow-ups for recurrence
Couple that with the fact that the study population contains some of the worst cases of HNC (Floor of Mouth stage 3&4). I just don't think we loose many to dropouts that completed treatment. Last sentence is just my uneducated assumption.
On the flip side of this,I don't know if 3-5 are common practices in some of the countries.
"Seems they got in early and approved and the trial is still running.
Must be nice to be a big pharma"
Lol, that's the truth! Thanks for the info lightrock.
Guys, I don't know about Opdivo, but wasn't Keytruda just approved this year for head & neck?
https://www.cancer.org/latest-news/fda-approves-keytruda-pembrolizumab-for-head-and-neck-cancer1.html
Well, I for one really appreciated it. Lol
Sushi, thanks for another great article and for the heads up on Ergomed update.
From the Ergomed update 96% complete..
298×96% = 286
Yes, the stat guys on this board are awesome.
I feel like a kid at Christmas thats been staring at a shiny box for a solid month.
Or in this case years. Lol
This is a very interesting development! Just gonna throw my two cents in on this.
1. They probably wouldn't schedule a public event before the IDMC meeting (Been very silent lately).
2. This really wouldn't happen if negative results were known/suspected.
Excited! Thanks Sushi.
Is it just me, or is the first bullet point from the 10q businesswire report somewhat interesting? To me it sounds like a noncommittal way of stating that Ergomed "may" be in the confirmation & data review process. Thoughts...
Thanks lightrock, definitely would want to see efficiency in the aux arm or there could be some questions raised. Hopefully, dropouts will be contained as well.
Just never considered the aux arm being included to maintain the study power. I only thought of it as control vs test. Test successful, then test compared to aux, was it the mk or CIZ driving efficiency?
The thing that's got me stumped is the 15.5% maximum dropout rate leaving 784 evaluable patients. That would include all 928 to reach 784. I'm assuming (based on Fosco's post) that the evaluation will use the 3rd arm, if required, due to the dropout rate.
Nevermind, reread the post. I'm good.
Fosco, help me out here. Apparently I'm a little confused. How is the 3rd arm evaluated in this? I thought the 3rd arm was followed, but not truely included in the overall evaluation. Thus, two arms 397 patients each (test & control). Dropouts from these two groups primarily effecting the endpoint. How does the 3rd arm play in this? I'm almost embarrassed to ask since I've been invested in this so long and apparently don't understand. Lol
Oh and one more thing, if refusing surgery (due to a response) is a dropout qualification. I personally believe this could be a driver for high rates in the test arm. ;)