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I want to say it will be closer to $10 in 6 months. UK will likely approve sooner than FDA. Once UK approves, Philippines will order right away. Canada may authorize before US too. FDA EUA will likely be in 3 months. This whole thing about bankruptcy, don’t believe a word. The same lies were spread for CVM, NWBO for the last 10 years. They are still alive and kicking, on the cusp on releasing their pivotal ph 3 data, 10 yrs in the making!
As I suspected earlier, UK and Canada will likely approve before US. UK has shown recently they are more organized and open to accelerated approvals. Furthermore, not as many big pharma lobbyists and big money influencing their decision making.
Couldn’t agree more. I believe I have provided more KOLs names that support CYDY than the publications some of the folks think they provided validating their statement against CYDY! ;)
Shorts increasing activity over the last 24 hours (particularly on a weekend) point to me they are still worried the stock could gap up on Monday. If they were so confident and it was as clear cut to them that the trial failed, why would you need to come out in numbers over the weekend to justify over and over again! Perhaps they only have a few days to cover before EUA is granted by one of the regulatory agencies? I wouldn’t be surprised if UK, Canada and Philippines authorize LL in their respective countries before FDA does. If you are able to reduce 6 days of hospitalization that’s significantly less burden on healthcare system, families, and importantly better patient care! Of course, they will review the data carefully, but it would be stupid not to when they also know well that most vaccines may not be as effective against new emerging mutations and who knows what another 6 months could bring. The UW articles from couple of days ago forecasted 150k-200k deaths in the US over the coming fall/winter season. Unfortunately, we are not going to get back to normal for a while until at least 70% of the world gets vaccinated and that is going to take another 12-18 months at the very least, if not more. Once the borders open up a bit more, you can imagine new mutations will be brought in bigger numbers from other countries even if we lead the race on vaccination.
It’s interesting that Dr. Seethamraju is going to be part of the investor call Monday afternoon.
Thanks. Could ours have more separation at 42 and 60 days? And wouldn’t FDA be interested in looking at this?
Can someone summarize how our results compare to what RLFTF reported for Aviptadil about 10 days ago?
I agree with this theory. Assuming they signed NDA before doling out this loan, I’d expect some close knit circle of family, friends to be party to this leak? And that could result in some buying next week? Just conjecture at this point...
Excellent and thanks for summarizing this so nicely in a post!
Me too. Didn’t hit my under $4 target this week! CYDY has held up really well this week despite strong selling pressure on biotech stocks. If it closes at the current price, it would be break-even for the week, whereas major relevant biotech firms are down roughly 20% this week!
By the way, how many would someone like Gilead have?
Great point! ;) wow, the stock is up 15% already. Leak?
Agreed. However, I’d rather trust a person who has the credential of 16 successful BLAs than other posters on this board making claims otherwise!
In KOLs we trust. Why would Dr. Rahman who is such an accomplished scientist and executive with a history of 16 successful BLA with the likes of Pfizer, JNJ, Novartis join the company in a leadership position. He is the captain of this ship from a regulatory perspective and I trust him to deliver!
Ahh, got it!
Why would Dr Rahman join CYDY? He is such an accomplished person with outstanding resume/experience with JNJ, Pfizer, Novartis and others highlighted by 16 successful BLAs. Needless to say, he believed in the potential of Leronlimab and knew he could get them over the line in multiple areas. Dr. Seethamraju from Mt Sinai was instrumental in connecting NP and Dr. Rahman, from what I hear.
I think NP is playing smart by providing data to UK MHRA and Canada as well. It's likely UK MHRA acts faster than FDA. I don't think FDA will take chances here given the crisis mode we're in as well as realizing that MHRA could potentially dictate how many doses they get v/s FDA, if they let this linger too long. Plus HGEN doesn't address most severe & critical patients. So I am not too concerned.
Times are certainly different now than late 90s or early 2000s with the advancement in social media & technology infrastructure. Zoom, YouTube, Twitter, Pubmed, Google, etc. to name few. Folks can now participate in video presentations, listen to KOL researchers/clinicians talk and present data, read latest scientific publications as soon as they are out, and so on....provided you're willing to do due diligence....I'd rather trust KOL scientists, peer-reviewed publications than FUDsters, and to some degree even company reps....as you say, these KOLs wouldn't stick their neck out consistently and passionately if they didn't believe in the potential....
This is great info! FDA is probably having discussion with CYDY around scaling up manufacturing, so US government can purchase more doses than what Samsung can promise this year. Is it possible that they give us around a billion dollar funding under Operation Warp speed, in addition to another billion dollar order? And could we also be major beneficiary of the new stimulus?
The 25% drop (over this week) projection by the shorts is not quite working out so far! Not even close. We are trading about 3-4% lower than the close on Friday, whereas major vaccine plays such as NVAX, MRNA are down approximately 20% for the week. So we have done really well because the market believes we have good news around the corner and no one wants to sell. Shorts are trapped!
All I would say is FDA wouldn’t entertain them if it was all smoke and mirror! And the KOLs (at UCLA, Mt Sinai NY, UCSF, former director of clinical virology @ Standford, and others) won’t stick their neck out continuously & passionately to support the science. I would rather trust them.
My dad’s birthday is March 18, and it’s been lucky for me. On my sisters birthday in October, we had a nice run up to over $2. Also March 18 happens to be Thursday when either NEJM or Lancet publishes! Could we have TLD in 2 weeks?
Center of Excellence awarded to UCLA, King’s College London for brain tumor research!
Excellent, thanks!
New job posting at Advent. Was also posted on LinkedIn today.
https://adventbio.peoplehr.net/Pages/JobBoard/Opening.aspx?v=3999edb3-5cb9-4fce-8b8c-bfc87f27eba0
Totally. He is going to be our man! Been there, done that, and tasted success. And not to mention the network you accumulate having worked at executive level with big pharmas. Plus MGH, UPenn background. Unbeatable!
Seems like he has access to full data and has done the analysis! I wonder who was complaining they haven't released the data. Perhaps they should reach out to him! ;)
And a big order from US government coupled with media stories everywhere in a couple of weeks, if not sooner!
Someone knows something!
Yeah, I bought some more earlier today....but would want to buy bigger portion if it dips under $4 again....Just ain't happening! I guess shorts aren't getting enough support? Don't want to run into another GME like scenario perhaps?
In my mind, FDA would have already kicked us out if the data was not promising and NP had to PR that by now. The more days that pass by is actually a positive as they are likely discussing various deals behind the scenes. Having said that, I'd expect a PR around mid to end of March.
Dr. Rahman is now the captain of this ship (from a regulatory perspective) and he has the necessary skills & leadership qualities to bring us home given his experience over the years at J&J, Pfizer, etc. getting various drugs approved. And I can not tell you how important this is having worked with one of top 5 medical device companies in a leadership position over the years.
Agreed. I predict we have at least $1 billion order from US, UK and/or Canada by end of March. And Philippines has already committed to purchasing 100k doses as soon as EUA is granted by one of the regulatory bodies. Their real challenge will be how soon can they manufacture and deliver. Will FDA and US government put them in touch with a US manufacturing facility to scale this up?
This is great! Confirms the value of Leronlimab!
Very long NWBO, but I am a little concerned about her (LL) statements regarding patent. See below. Can you address that? Thanks!
Q: How can we use software take everything that’s out there and make the trial process more efficient?
A: Right now, we’re starting up a trial, which personally I think would be very promising. It’s basically using vaccination in combination with a PD-1 inhibitor. We’re working with Merck on that in combination with Poly ICLC, which is a Toll-like receptor. That’s another company called Oncovir.
So, with a DC vaccine, like I said, we can just make it ourselves. We can’t scale up as an academic institution or a small company, but if that were part of the company we could scale up. To make the vaccine, you just need a manufacturing GMP facility. But the problem there is the autologous dendritic cells are hard to get patented. You could patent it, but it’s hard to defend that because it’s really the patient’s own tumor, right?
So, the patents really are process patents and we could file one that tweaks things a little bit, and that’s essentially that’s what Northwest Bio did. They filed multiple patents just on little tweaks of the cocktails that are used to make the cells.
The other drugs are already made by other companies and they’re just an agreement. How do you patent something that is actually part of a patient rather than just patenting the process? And that’s why people have gone on to patent just individual targets. We could do that, but I wouldn’t invest millions of dollars on a clinical trial to do a trial of a vaccine for an individual target. I just don’t think it can work. So, I think the conflict is you could patent some—you could say, “Oh, I discovered this one protein that we can make a vaccine to and we could license it.” But my gut feeling is that is not going to be what will cure GBM. In a way, what I think will cure GBM is unpatentable. So that’s the dilemma. Does that make sense?
That’s awesome and makes sense! No wonder FDA is entertaining them privately. Will buy more tomorrow!
<<<<<Leronlimab is not affected by any mutation !!! >>>>>
Are you sure? This would indeed be massive, if true!
I think I heard Dr. Patterson say in one his calls last week that he’d recommend either Leronlimab or Maraviroc depending on the diagnostics test results, if a patient were to come to him for treatment.
CYDY could have a similar trajectory this year that this company went through last year. If so, we could be trading in at least 30s before the end of the year. https://amp.ft.com/content/22d3805e-c304-4d95-ae32-f559ff34886a?__twitter_impression=true
Interesting news pieces about big pharmas, and the role of some of the media companies in such activities:
https://www.classaction.com/news/stat-news-credibility-problem/
https://www.healthnewsreview.org/2017/09/a-blow-to-stats-credibility-public-relations-firm-may-have-ghostwritten-op-ed-praising-drug-reps/
Music to my ears! Would love to add more under $4 before EUA in a couple of weeks. My prediction is it jumps over 100% on the day of EUA given the massive short position.
If FDA had known all along that this was a failure, why would they be wasting their precious time to entertain CYDY? They believe, KOLs believe, and we believe!
By the way, big pharmas compensate scientists and their key advisors all the time. Are you suggesting that these leading scientists/academics would put their career on the line for big pharmas or small biotechs, if a drug doesn’t produce meaningful outcome consistently? And you are welcome to provide any proof that Dr. Yang, Dr. Seethamraju, Dr. Agresti, & Dr. Been have received stock/major financial compensation from CYDY?