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The only way IMO is either the BLA approval that I stated to take the stock over $1 or a big pharma deal is also possible yes. It will have to be a good deal with lots up upfront cash and milestone payments. So yes these two only. Anything else probably won't move it higher.
The problem is that OTC is riddled with 4 players that you can't get past.
Even with all the good news the reason why the stock won't move higher is because of the 3 players I noted above. They are:
1.) NITE
2.) CANT
3.) flippers
4.) Maybe short-sellers as well
The problem is that all those players above are an overhang. Without a reverse split it will be very hard to get uplist to a higher exchange. I'm not saying it's impossible but you have to counter all those players in the way. What may move it past $1 might be if Pro-140 announces FDA approval for the combination. Then again it may not. You see the cycle here?
In addition to those players above you have the overhang of Paulson with shares. It's just too much for the recent news to counter. But truth be told IMO to eventually uplist to a higher stock exchange or move past $1 a reverse split will be necessary.
Well I have a lot of shares now, the most out of any other stock and that's because of the science.
The financing situation sucks I'm not gonna sugarcoat it, but eventually something is going to give either an offer for a buyout or a licensing deal. Is it taking a lot longer than expected? Yes, but long-term I think leronlimab is a potential blockbuster drug.
I will give you an example. Look at HUMIRA it started off as a typical human monoclonal antibody for Rheumatoid arthritis(RA). RA is an immunological disorder. HUMIRA stands for HU - Human M- monoclonal Iga antibody Rheumatoid arthritis. The point being is that it started off as only treating one indication and now treats multiple indications. It has ended up being worth a $15 billion a year drug.
What's my prediction? Well, pro-140 is also a monoclonal antibody granted it targets CCR5 instead of HUMIRA which targets TNF - tumor necrosis factor instead. The point is that if pro-140 can be adapted to cancer, multiple scelorisis, GVHD, HIV, and other indications then it too can eventually become a billion dollar blockbuster like Humira. Leronlimab has shown strong efficacy in HIV monotherapy with a 92% response rate which is very strong for a single agent. Other HIV drugs have to use 2 to 3 agents combined. The point being is that for Pro-140 not only may it be able to treat all these diseases but it may be a monoclonal antibody that severely avoids the side effects associated with other monoclonal antibodies.
You know how long it is to a approve a drug that is not Fast track? Regular approval timeline without Fast TRack is 9 to 12 months.....
If Dr. pestell can convince someone, that being Merck of Pfizer then I believe a deal is on the board. I didn't know until the video on CytoDyn's website that Merck and Pfizer each started their own CCR5 cancer pipeline testing. Considering the patents lie with Dr. Pestell they will eventually have to do a deal IMO.
I have been accumulating like crazy as well as the time ramps up for Q1 2019 to finish the rolling BLA submission.
They are bad when done with no catalysts. As I stated if they do one, 1 or 2 days before the BLA filing that's good. For instance, reverse split on a Monday, then the very next day release BLA filing news. That would work. However, a reverse stock split for no reason = bad. Get the drift now?
Example, Sarepta Therapeutics did a reverse stock split 1 to 2 days before releasing its phase 2 DMD results. The stock shot up to 12 the first day, then 24 the very next day.
It's all bout the context. if they time it with a BLA filing or partnership it's good to do a reverse split.
LJPC La Jolla Pharmaceuticals did a reverse stock split and uplist. Ran to $45 per share and is now back down to $12 per share but the drop has to do with market prospects, and bad market selling.
ADXS did a large stock split from .04 cents per share to $4 or $5 per share I think it was a 1 for 200 r/s or something like that. Anyways on good news it ran to $30 per share now down to .20 cents per share.
The point is those companies ran higher after doing a reverse stock split and uplisting to NASDAQ. You can check the history at those times when they did the uplist and r/s they did so when there was no phase 3 done and no FDA approval yet.
Cytoydn has already completed a combination phase 3, and ready to file a BLA. Plus it is near on possibly finishing up the monotherapy as well with a label expansion.
Look if a company is in phase 1 and phase 2 like ADXS, RXII, LJPC were then I don't recommend a reverse stock split. What I'm saying is that CYDY is close to a BLA filing. if it coordinates a reverse stock split a few days before the BLA filing it will have established buyers buying up stock. It won't tank. The biotech you are describing is nowhere close yet to filing a BLA or NDA. Does that make sense?
I already explained it's because it trades on the OTC market. If CYDY expects movement on prospects it has to uplist to the NASDAQ. The OTC is filled with flippers, traders, and short-sellers. Yes there are some people who buy long shares and are investors. However, the volume precedes those who manipulate stocks. NITE and CANT are the top 2 in the OTC that play in a range generating money. We need to uplist to a higher stock exchange. Also institutions , most of them, are forbidden from buying stocks on the OTC. Even if the phase 3 trial passed, BLA is being filed etc. a big insititution is not allowed to pour any money due to rules, and liquidity concerns. If I was CEO I would set up a reverse stock split about few days to one week before A potential BLA filing. Thatway it can be uplisted to the NASDAQ. That will get the stock price moving instantly.
As for the CEO's puzzlement of stock price that's easy. It trades on the OTC. if they want a more reflective stock price they will need to reverse stock split and list on the NASDAQ. Anything short of that and the stock price won't move much In my opinion. What's your guys'take on that?
So what I gather from the Conference call from December 12th is that DR. pestells company owns the patents for HIV pathway antibodies and cancer. Merck and Pfizer have their own HIV drug being used for cancer, but does them no good because they don't own the patents. Dr. Pestell's company does. In essence, I believe this sets up a buyout scenario. If Merck or Pfizer wants the patents it's going to have to buyout Cytodyn or partner with them. Anyone else hear this on the call?
I have around 43k shares around .46 cents average of CYDY
ended up going slightly over with 11 million shares but good price 6.75 so not that bad. I'm happy I think it will head higher once dilution is over. That means it won't start move up prob till next week.
PTI is currently not partnered with anyone right now. It is seeking a partner, but if it can't secure one it will have to raise cash. however, given the results I don't see them having a hard time raising cash.
Plus you have the triplet combination data for PTI-801, PTI-808, and PTI-428 due out this quarter. That means these results can be any day now. if the triplet is shown to be superior to Vertex's triplet, then the stock will rocket higher, much higher. That would be a good time to raise cash.
We already know PTI-801 and PTI-808 work. now what is being added into the mix is PTI-428 and I believe that should boost the FEV1 by a much higher percentage. If the triplet data comes out better than the stock will gap higher again.
Holding many shares long since 1.90 . Will not sell at all retirement stock incoming. Even with dilution coming it won't matter, triplet data is due Q4 2018. That means triplet data could come out as early as next week. That would be another potential gap situation if FEV1 is shown to be high.
Did you see? For their PSC drug primary sclerosis cholangitis they won best foundation award from the AASLD for translational medicine. Emricasan is the real deal it will go places.
You are thinking about the secondary endpoint for 20%
The primary endpoint is looking for the mean change in HVPG to be stat sig compared to control. Without knowing the numbers for drug and control that' can't be determined yet.
No. it would have to be higher from control. stat sig. although placebo doesn't do anything in respect to HVPG.
In essence in the pilot study
8 out of 12 patients achieved a > 10% reduction
and 4 out of 12 patients achieved a >20% reduction.
So the company chose to only recruit patients with over 12 mmHg (mercury) meaning severe portal hypertension.
Because CNAT has already shown to reduce fibrosis. In the POLT study from F3 through F5 fibrosis population it achieved a 95% response rate. Even though the title read as a fail, in essence the trial was a success. If you were to also take out the 3 placebo patients with F6 level fibrosis at 100% the trial would have met on the primary endpoint.
I think it's shown on the latest presentation slide or mentioned by the CEO.
https://clinicaltrials.gov/ct2/show/NCT02960204?term=conatus&recrs=adf&rank=3
" Patients will continue to be followed for clinical outcomes in a six-month treatment extension period."
https://ir.conatuspharma.com/news-releases/news-release-details/conatus-announces-completion-enrollment-encore-ph-phase-2b
The raise is just put in place. They have funding till the end of 2019. However, they are working on other stuff besides the programs they are partnered with Novartis. They are going after Primary sclerosing cholangitis, lung fibrosis, and other diseases. The deal with Novartis is just for the 3 trials ongoing now.
I think it will be in October 2018. The reason why I state that is because the study also has a 6 month extension period as well thereafter.
That's because CANT and NITE short about 80% to 90% of the OTC market.
That's true, but the POLT study didn't fail because emricasan didn't work. It's just that the biopsy that was done had 3 F6 fibrosis placebo patients obtain 100%. For a severe cirrhosis of the liver and to obtain 100% was a major anomaly which is just not possible. My thinking is that the biopsy was done on a part of the liver that was not affected and was fully healed. As for the ENCORE-PH I think it has a better shot because measurement is with HVPG measuring the portal hypertension vein of the liver, and not a biopsy. In addition, the POLT study only used one dose of emricasan 25 mg. The ENCORE-PH study is using 3 doses of emricasan 5 mg, 25 mg, and 50 mg twice daily vs placebo twice daily.
yes they need funding from somewhere, Honestly I don't see why they don't just find a pharmaceutical partner, Sure they have to give up on royalty sales but it will fund the company to complete the BLA, and have cash for cancer/MS/ etc. other stuff in the pipeline.
Now I see why the BLA filing is somewhat delayed, I looked into the 10-k filed today, and found this:
"Due to our current liquidity condition, our CMO has suspended certain preparations for future commercialization activities which are integral for the timely completion of a BLA filing. Relations with the CMO remain accommodative and resumption of certain CMC activities will be contingent on a material improvement in our liquidity. Certain other CMO activities related to BLA preparations remain on schedule at present, and provided liquidity improves, we are confident that existing BLA schedules will be maintained. Several qualification batches that may be commercially suitable remain on schedule for year-end 2018, but may be delayed into early 2019, unless liquidity improves in the near future."
That means they are strapped for cash real bad. They need a partnerhship or other non-dilutive financial boost. But that's the reason for the delay of the filing.
primarily though in the Conference Call the CEO stated there would be an update in the coming weeks on something about Multiple Sclerosis.
Bucky listen to the conference call again. They are not recruiting more patients right now. They spoke with the FDA and if the 10 patients they currently have show the same results from the pre-clinical study they will forego recruiting the other 50 patients. It was in the CC asked by that Physcician towards the end.
What do you guys think of the potential for GlaxoSmithKline and Jannsen's injection for HIV which only requires 6 injections per year (one injection every two months). Data from late-stage study expected by end of 2018/early 2019. Don't know yet if it will be successful, but from what I can see it still has side effects such as diarrhea, cold, and others. What do you all think?
https://us.viivhealthcare.com/us-news/us-articles/2016/viiv-healthcare-starts-third-phase-iii-hiv-treatment-study-investigating-long-acting-two-drug-regimen-of-cabotegravir-plus-rilpivirine.aspx
Update: I just noticed though that the bottom has a lot of severe side effects. Also its an intramuscular injection that must be done likely in an outpatient setting. I still think that Pro-140 will be a better treatment option IMO.
yah but every time you need treatment you have to drive out one hour or 2 hours where you need to go. How convenient is that?
Apple almost went bankrupt, but Microsoft gave them money to keep it alive. That's because Microsoft was worried about having a full monopoly and no competitor so it saved Apple. Look at Apple today. Regeneron Pharmaceuticals used to be at $5 per share and look at it now. PYCY used to trade at 0.80 cents per share and then finally got bought out at $260 per share. Can't judge an investment based on the current price, that's why so many people never succeed trading on the stock market.
no. As of right now those who took 525 mg pr-140 mono we have 70% response rate. Patients who didn't respond on the 525 mg will be boosted to 700 mg. That should potentially get the response rate to 80% - 90%. But nobody knows yet for 700 mg until they release that later.
Correct once the patients took 525 mg of Pro-140 monotherapy, the response rate reached 70%.
With 700 mg of Pro-140 how much it will go up from 70% is anyone's guess. I'm banking on 90%.
It's 70% but he keeps saying 75%, but it doesn't really matter anyways I expect the 700 mg to bring up the response rate to 85% to 91% anyways.
Especially when they have a monoclonal antibody that can go after HIV, cancer, Multiple Scleroris, GvHD, other autoimmune diseases. What big pharma wouldn't want a safe version of a monoclonal antibody that could target all these diseases?
CEO even mentioned that Pfizer is working on a CCR5 drug in cancer of its own I believe, but I think he stated they have more toxicity on their version. I will have to go back and listen. But that's what I thought I heard.
NITE and CANT two of the biggest crooks on the OTC playing with all the stocks. Oh how I would love to get rid of them both and put them out of business