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Q2 and yes possibly Q3 maybe.
That's okay read my long reply. I'm Terry. I don't believe the author did enough DD on the company. A simple browse through of the last 2 press releases would have shown that negotiations for potential licensing are in the process.
Everyone here was scrambling why they chose to start 8 preclinical studies for cancer using leronlimab well there's your answer.
https://seekingalpha.com/pr/17417467-leronlimab-pro-140-reduces-98-percent-human-breast-cancer-metastasis-mouse-xenografts-6-weeks
That's my thinking. If they didn't think they were going to get an upfront payment deal or a licensing deal, they wouldn't have shelled out $1.5 million to run 8 preclinical studies. The reason for doing so that I can think of only can be because they are set to receive some type of partnership deal or funding.
Thanks Misiu and thanks for the entire board for your kind words. I still believe that CytoDyn with leronlimab could possibly eventually achieve similar prospects like AbbVie's Humira and target multiple indications.
That's true, but deals take time because there has to be a contract signed. Generally it depends when the talks started. But to finish a deal maybe a few months from now, possibly longer. Either way, the point is they just need to secure a partner to market the HIV indication. The GVhD indication is also good as well. It seems the partner is interested in that indication also.
I think people are missing the most prominent item in the Press release. The news about the 8 preclinical cancer studies is good news, but read this from the PR
"We are also delighted that we have entered into discussions for commercializing leronlimab in 2020 and are currently considering a potential offer for royalties and milestone payments in connection with a commercialization partnership for HIV and GvHD indications,” added Dr. Pourhassan."
https://www.cytodyn.com/media/press-releases/detail/315/cytodyn-to-initiate-8-pre-clinical-animal-studies-with
I don't believe they would have started that many studies if they didn't feel confident they were going to receive upfront payment from a deal with pharma.
The reason why is because the cancer study is technically a phase 1/2 study. Phase 1 studies are normally in place to test out safety. Of course, as we know the safety of leronlimab does not need to be tested yet again. Therefore, any other indications can go straight to a phase 1/2 and if positive results are achieved can go straight to a phase 3 program.
I will tell the entire board right now that CYDY may seem weak right now because it still trades on the OTC and still looking for approval. But I believe that Pro-140 has a good shot at potentially becoming another Humira. Humira generates $15 billion per year for AbbVie. The reason why is that HIV is just the start, then you have potential with cancer metastasis, then GvHD, then multiple sclerosis, NASH, and other autoimmune disorders. I believe that the future of this product is strong. yes it's going to take years to get there I get that, but I believe it has the potential to become like Humira. That's what I'm holing out for. Humira also just started off as a monoclonal antibody only for 1 indication. Humira's first approval was back in 2002 for only Rheumatoid arthritis, from there it expanded to other indications. I believe Pro-140 has the ability to do the same. It would be smart for a big pharma to get its hands on this monoclonal antibody now, because it's very rare for 1 drug product like Pro-140 to be able to target multiple indications.
Dr. pestell has stated that CCR5 is being investigated for metastatic TNBC. metastatic means the cancer has already spread to other organs or parts of the body. It does not mean it is only in severe state in the breast cancer only. The term metastatic implies that the cancer started from there and has already spread to other organs and parts of the body.
As for CCR5 Dr. pestell has noted that when CCR5 is implemented it stops the spread of cancer to other parts of the body, when it is removed then the spreading starts to occur again. That was noticed in animal models. What remains now is to see if this can be replicated in humans.
Totally agree. The biggest item that Dr. pestell noted and why he merged his company with CytoDyn is because he stated he not only saw the efficacy side of using CCR5 as a target but Pro-140 had perfect safety profile. That's the problem with many cancer treatments for metastatic disease, patients have to go through chemotherapy which is highly toxic. If pro-140 works out for cancer too that would be amazing for patients not just investors.
You apparently are either trolling or didn't read the PR. The CEO stated that they are seeking an upfront payment from a partner .....
The higher amount is going to be charged for Pro-140 HIV because it will put it in line for when they launch the drug in cancer as well. They want the pricing to be closely similar.
I will probably write an article upon the cancer data or approval of combination therapy pro-140
Presentation on right now CYDY, just started, I thought it wouldn't start until 4:30 pm est but is started 11 min early.
The BLA submission was pushed because of the Shutdown.
The best time to uplist would be with catalysts. So a week before the final BLA submission would be a smart move. Also before regulatory approval would also be wise. But not at this point in time, unless the CCR5 cancer data is mind blowingly good.
Here I will summarize it for your nicely.
He's long Gilead Sciences, and doesn't like CytoDyn.
He can't with a straight face say that pro-140 wont' take market share. It's not all about just the once a week injection. Also notice how they never mentioned anything about safety.
Pro-140 has no serious side effects or serious adverse events, where as Gilead's HIV drugs all have loads of side effects. I won't list them here because it's a long list just have to google the drugs and see all the side effects.
Depends on the data they release. If they prove a theory that CCR5 can stop the spread of cancer metastasis that would be a game changer in the cancer space.
Everyone is frustrated and have the right to be. But to change from being optimistic one day to entirely negative makes no sense. Nothing has drastically changed. Especially since they hired Welch today who is responsible for performing very large merger/acquisitions. I view today as a huge positive. Everyone here is too focused on the daily swings and that's the issue.
If anything this selloff is made up, irrational, and people selling for pennies. The way I read the news today with hiring Welch is that he was responsible for large mergers and acquisitions. They brought him in to take care of the financing aspect of a potential merger/Acquisition. If anything I would be buying more CYDY after today's news, not selling....
the CEO nader answered that question. Someone asked how far along in negotiations they are. I'm surprised though he was allowed to answer that though.
Cytodyn is in talks with Merck to potentially use Merck's pill and then Pro-140's injection. Also in talks with China biotechs as well for biologic. This is from the end in questions of the presentation.
yah what's up with the music in the presentation? On another note, looks like the 1st half of 2019 is going to be an amazing time for CYDY on multiple partnerships, and BLA filing for Pro-140 in HIV combination.
Slides are up and for BLA the non-clinical submission is completed. Just need the last 2 parts now. Also partnership being explored for leronlimab in China, USA, and other countries. Plus licencing for prostate cancer test could be completed by 1st half 2019.
The FDA meeting with the go ahead to do a phase 3 is important. However, the average cost for a phase 3 study is $40 to $50 million dollars. Both you and I are aware that the company doesn't have $50 million dollars in its coffers to even start the study.
The only way to get the study going is for a big pharmaceutical company to pony up the cash to initiate it. But what market opportunity exists for the drug. What company that you know of is going to give $50 million dollars to allow IPIX to start a phase 3 study?
Because share price and valuation depends. Depends on partnership, depends if BLA gets filed, Depends if Pro-140 is approved this year. Can't really assign a value on "ifs"
The problem is not tax selling and you know it. The reason why there isn't a lot of buying now is because there is a cash need right now. Either through a cash raise or a partnership. One of either is going to happen. CytoDyn will be forced to raise cash to file the BLA, private offering with big shareholder, or big pharma partnership. That's why the stock is stationary right now. Investors don't like uncertainty. Once Cytodyn gets the cash need done somehow the stock will recover.
To be fair the problem right now with CYDY is money. It needs cash to finish filing the BLA in Q1 2019. AbbVie is loaded with cash and can get filings and products approved easily. Plus AbbVie has more experience with drug approvals since it has been doing it so long.
mark My words now, Leronlimab has the ability to potentially become as powerful as HUMIRA. HIV is only the starting target, you have cancer, GvHD, multiple sclerosis, and other immunological disorders. If it all works out it has massive potential. Is it risky in the other indications? yes. But I believe Leronlimab has the ability to become a blockbuster product.
maraviroc was on old drug already approved, Pfizer and Merck are each working on a new CCR5 cancer drug.
I think it will be good if it reaches the market. Right now patients have to take pills every day. With Pro-140 it will be just a subcutaneous shot once a week at home. The big pharma are working on less infusions but you still have to go outpatient to receive those.
Correct. As I stated there has to be discussions ongoing. You have either GlaxoSmithKline, Gilead which may want a piece of the HIV product. Then you have Pfizer and Merck that will want to get a hold of the patents possibly for CCR5 from Dr. Pestell. Then you also have the potential to license out the genetic testing product as well.
Yes based on the notion that Pro-140 being approved even as a combo would eat into Gilead's market share. Even then don't Pfizer and Merck needs the CCR5 patents that Dr. Pestell owns for CCR5 antognists in cancer? many avenues in my opinion.
Article I wrote on CytoDyn enjoy! https://seekingalpha.com/article/4230899-cytodyn-gearing-bla-filing-combo-hiv-treatment?v=1546296267&comments=show
I already explained that the OTC is a bad place. That's why I'm advocating for the stock to uplist to a better exchange like the NASDAQ. There is short-sellers there too. The problem is that on the OTC it is not going to gain traction as easily because of the exchange it is on. For many reasons, limited exposure, no institutions can buy shares on the OTC, short-sellers, NITE, CANT, flippers etc etc.
I mean let's be honest here had CYDY been on the NASDAQ it would have been trading at least $10 to $12 per share right now at a minimum. Of course with a smaller float because of a reverse stock split. But still it would have been doing much better than now.
Not true in the beginning they make it work.
LJPC was on the OTC and did a reverse stock split from .26 cents per share. Within the first year it went to $20+ per share hit a higher of $45 per share before dropping to where it is now. But it was able to raise cash at higher levels because the stock was at a higher price.
Advaxis did a huge reverse stock split from .04 cents per share. Went to $8 or $12 per share in the short-term then reached $32 per share before falling back down.
The point is that if there is good prospects, which there is for CYDY as it is close to filing a BLA then it can do better than those 2 companies noted above. Because it has already passed a phase 3 study. Those other companies noted above only uplisted while their products were in phase 2...
So to your point reverse splits without a major financing in place at first do not go straight down the toilet. That is false and wrong.
I would prefer a partnership too, hopefully one of the other big pharmaceuticals step up. Because so far despite all the latest data I haven't seen Gilead make a push yet. I hope you are right, but getting a partnership with big Pharma is not that easy. Lots of paperwork and rules involved.
Why? You don't lose money on a reverse split. You only lose shares, but the price you paid or gained remains the same regardless.