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I think Pharmacyte's market cap of 50 million is going to tempt some investor(s) or any biopharmas sooner rather than later. It is just too low hanging fruit.
These upcoming conferences will add even more exposure for CIAB.....remember a partnership or buyout will happen when we least expect.
To all have a great holiday weekend....
A Scarcity of Biotech Assets for Buyouts?
I believe this bodes well for Pharmacyte. Also, we too have non-disclosure agreements.
From the article:
Gabelli’s Jing He argues that a “scarcity of valuable biotech assets” available for purchase by bigger biotech and pharmaceutical companies should keep a floor under Medivation (MDVN)–
There has been speculation that Medivation has signed non-disclosure agreements with Pfizer (PFE) and Amgen (AMGN).
Since the valuation of the biotech sector has dropped over 30% since mid-2015, large pharmaceutical and biotech companies have been eyeing valuable assets especially in cancer.
http://blogs.barrons.com/stockstowatchtoday/2016/05/20/a-scarcity-of-biotech-assets-for-buyouts/?mod=yahoobarrons&ru=yahoo&yptr=yahoo
This is making someone very nervous. I like it....
Taking into consideration of Pfizer's purchase of Anacor, what would Pharmacyte's value for diabetes alone be worth??
Snippets from the article:
(Reuters) - Pfizer Inc <PFE.N> will buy Anacor Pharmaceuticals Inc <ANAC.O> in a deal valued at $5.2 billion, net of cash, to gain access to Anacor's experimental gel for treating eczema.
There have been no new molecules approved for eczema, or atopic dermatitis - a common, relapsing, inflammatory skin disorder that affects about 18-25 million people in the United States - in the last 15 years.
http://finance.yahoo.com/news/pfizer-buy-anacor-pharma-5-2-billion-deal-105636786--finance.html
Pistol,
Excellent find on this article. Pharmacyte's name is certainly getting out there......but we also know JNJ, Lilly, Novo Nordisk, Bayer and Sanofi definetly knows about Pharmactye diabetes treatment too.....
ASM news?
Has anyone heard information regarding our potential Annual Stockholders Meeting?
Since we have a fiscal year end Apr 30th I would expect some news soon. Might we get an update or Q&A session???
Many of our Milestones have been completed or are in WIP. The following are TBD:
PharmaCyte will conduct periodic shareholder calls, rather than communicating through shareholder updates, with the CEO responding to questions during the calls.
PharmaCyte will hold an annual shareholder meeting.
I have to believe that Pharmactye will know if it works as expected by the 3rd month. And every bio/pharm company will know as well. There are no secrets in these trials.
Now, on to diabetes and what I would like to see is a partnership and milestone payments......
This is why Pharmacyte's PC treatment will be successful. We need it NOW.
http://health.usnews.com/health-care/articles/2016-05-03/additional-treatments-offer-little-benefit-for-pancreatic-cancer-study
From the article:
TUESDAY, May 3, 2016 (HealthDay News) -- Additional treatments for locally advanced pancreatic cancer don't appear to boost survival, a new French study reports.
Researchers looked at the effects of adding a second drug -- erlotinib (Tarceva) -- to the initial round of chemotherapy. They also tested whether adding radiation to a second round of chemotherapy (chemoradiotherapy) would offer any survival benefit.
Unfortunately, the addition of the second drug didn't help people live longer, and those on chemoradiotherapy didn't fare any better.
The study was funded by the pharmaceutical company Roche, the maker of Tarceva, and the French National Institute of Cancer.
More than 53,000 Americans are diagnosed with pancreatic cancer annually, the U.S. National Cancer Institute (NCI) says. About 42,000 Americans die each year from the disease, the NCI reports.
The new study focused on 449 people with pancreatic cancer. Their average age was just over 63.
All received standard four-month chemotherapy with the drug gemcitabine (Gemzar). Gemzar is currently used to treat a range of cancers, including pancreatic, ovarian, breast, and non-small cell lung cancers, the drug's labeling information says. For the study, about half the patients (219) also took Tarceva along with Gemzar.
After completing initial treatment, imaging tests revealed that 269 patients appeared to have tumors that were under control. That meant their cancer was stable and didn't appear to have spread, or metastasized.
But the tumors couldn't be surgically removed because they had developed around the arteries surrounding the pancreas, study authors said.
Is something imminent going to happen?
Very interesting trading day.....
This bodes well for Pharmacyte.
http://www.businessinsider.com/stemcentrx-acquired-by-abbvie-2016-4
"Our mission, which is similar to the mission of many other companies, is to cure or significantly impact survival for cancer patients," Scott Dylla told The Stem Cell Podcast in December 2015.
Venture capital firms are eyeing the M&A that's the bread and butter of pharma companies looking to build up their pipeline. For example, pharma giant AstraZeneca picked up a $4 billion stake in Acerta, a relatively small cancer drug. These deals happen all the time, and in the frenzy of M&A, things are getting earlier and earlier stage.
I have a suspicion CIAB will work as they have already gone thru Phase I/II and beat the gold standard at the time. Yes we have to prove again but you have to like the odds especially since CIAB is better now than before.
Also, Pharmacyte will never be followed by many investors. If results of PC clinical and preclinical of diabetes is very favorable the company will be bought before the "mass public" knows about it.
All I know is that every large Bio/Pharm is well aware of Pharmactye. That's good enough for me.
I do not think the pps will be effected much at this point.
But what this announcement does is put Pharmacyte on the "watch list" of many Bios/Pharms. The company now can be taken seriously. I think this is great news not only for PC but for the ever looming Diabetes treatment which is the gem....
Announcements will happen unexpectedly on both PC and Diabetes.
Yes, I would like things to happen yesterday but they are coming and I think soon.
Keep the faith.
Pistol,
I think some announcements are forthcoming in April or early May:
1. Has PMCB already met with the FDA (maybe on several occasions)?
2. Will PMCB announce submission of the IND or have they already done this and are waiting FDA response?
3. Will there be a "diabetes" announcement around April 22 to correspond with the interview with our consortium? Has PMCB completed a preclinical on "pigs" with excellant results and will they make an announcement?
Exciting times are here......
I wonder if Pharmacyte met with the FDA this week????
For you I would put the stock on hold. I recommend you come back here in 2 years to see what has happened......
Gents,
I like the optimism but BIG pharm will call the shots not Pharmacyte.
It will probably be bought out in the $3-5 range sooner than later and by a European Pharm Co. JMO
Rudy,
As we both know, diabetes is the "hidden gem" of Pharmacyte.
IMO a buyout will happen (unexpectedly) and since we are getting EMA funding I think a European Pharm Company will be the buyer. I also think the buying company will acquire AustriaNova for total control of the process.
A buyout "countdown" will start when Pharmacyte gets cGMP.
My take:
1. Trial design is finalized but not locations. My guess sites waiting for IND approval before commitment can be finalized. Still impressive list of sites.
2. # of patients may be less if results are extremely successful and thus trial could be ended early and PMCB applies for accelerated approval.
While we are waiting for the IND, has anyone heard what is going on with Diabetes??TIA
You do know that the upcoming PC trial is a 2/B phase . Previous phase 1&2 were extremely successful although there is a new target audience for this years' trial.
Diabetes trials and or partnership may be closer than any of us thinks.
Yes, Pw.
There have been certain posters on this board that have been criticizing Pharmacyte for lack of IP protection.
I believe this will end that charade permanently. However, these gadfly's will come up with another complaint to replace.
Just time to sit and wait for news on cGMP, FDA meeting and IND submission.
I want to thank the CEO for clarifying his initial PR.
From my perspective, it is all about submitting the IND to the FDA. When this happens (whatever date it is) it will be a game changer for the company. It is probably going to take longer than I thought.
Until then we wait.....
The doctors and research scientists working with Pharmacyte are the best.
However, at some time you cannot keep kicking the can down the street.
I have no issues with changing the trials. I think it was the right decision.
The issue I have is the lack of transparency relating to getting the facility cGMP. At this stage of the game you need to know when this will happen. They hired someone months ago to review the facility and then Chamow did an additional review. Failure to get this done soon will push back the study to 4th qtr 2016 and maybe even 2017. They will eventually run out of time and money.
Note the wording on yesterdays Pr:
in generating the bulk of the CMC information needed for the Investigational New Drug application (IND) we plan to submit to the FDA
Note the wording on 2016 milestones:
• The Austrianova manufacturing facility will become fully compliant with current Good Manufacturing Practices (cGMP) standards.
And:
• An Investigational New Drug Application (IND) will be filed with the FDA following a pre-IND meeting with the FDA.
Now we plan vs we will......Big difference.
Does anyone on this board know how long it takes to be granted cGMP?
I just cannot imagine we are still validating a brand new manufacturing facility. This does not pass the smell test to me. Is something else holding Pharmacyte back??
Common sense would dictate to me that there should be some estimated date of completion for cGMP? I would think the "experts Chamow" must have some idea. Even with some "wiggle" room.
I worked at several Fortune 50 companies and the lack of providing realistic estimates on projects I worked on would have put me on the unemployment line.... just saying....help Mr. Waggoner!
What some people fail to accept is that CIAB has been successfully placed in humans. And might I add beat the gold standard at the time. This is not wildly throwing darts at a dart board and hoping something sticks. These proven clinical trials drastically reduce the risks. And CIAB has been improved since those trials....
Nothing is 100% certain in life except death and taxes. However, the prestigious doctors and research scientists involved with PMCB is extremely noteworthy. And in fact, make CIAB even more likely to succeed in Phase 2B.
Our time is coming soon....
My opinion only:
Meet FDA pre IND by March 7
Submit formal IND by March 21 or sooner if minimal changes
FDA approval of IND by May 15
Announce start of human trials by August 15 (complex and time consuming ie multi sites)
It looks like Q3, 2016 is the new target date for the PC human trial. I hope this is the final timeline otherwise they will run out of time and money. See below....
The Company currently has approximately $3.0M in cash on hand (and no debt), which management estimates is sufficient to run
operations for the next 12 months. We estimate that the Phase 2b trial costs could range from approximately $4 – 6 million and take up to a
year to a year and a half, with data readouts at the six-month mark. With very lean overhead and a reliance on contractors for the majority
of its R&D, we believe that PharmaCyte can maintain its cost levels in areas outside the clinic. We note that a milestone with SG Austria for
$100K could be reached in Q3 CY16, as the first human patient comes into play as part of the clinical trial for pancreatic cancer.
Johnson & Johnson, ViaCyte Testing Possible Diabetes Cure
http://www.nytimes.com/aponline/2016/02/04/us/ap-us-diabetes-cure.html?_r=0
It surprises me that Pharmacyte does not have a partner(even though we are early on preclinicals) on our diabetes treatment. From my perspective, I believe we have a superior treatment...
snippet from article above:
"We do believe that it will need to be replaced periodically," Laikind said.
Earlier testing in thousands of mice over years showed the lab-created insulin-producing cells matured and produced the needed hormone inside the mice for as long as they lived, about a year, noted Laikind.
Because of the protective capsule, which is flattish and smaller than a business card, if something goes awry, the capsule can be removed immediately to prevent patient harm.
Below is an article on the high cost of insulin. From my perspective this makes Pharmactyes' diabetes treatment potentially more attractive and cost effective......
http://www.seattletimes.com/nation-world/patients-shocked-as-insulin-prices-climb-higher/
Two key points from the announcement yesterday.
1. Pharmacyte may not do a site study in Australia. I agree because it would just add an additional cost. The US is the main focus now.
2. The cGMP audit is done. Unfavorable news would have been reported by now. I believe we have passed.
Below are snippets from the article:
The morning session addressed how the clinical trial will be structured and conducted. It was determined that there will be several cancer centers in the United States, with a number of study sites in Europe and possibly Australia.
Chamow has already performed an inspection and audit of Austrianova’s live-cell encapsulation facility in Bangkok, Thailand.
Interesting reading:
While presenting at the J.P. Morgan Healthcare Conference, CEO Alex Gorsky laid out critical details to J&J's acquisition strategy.
http://www.fool.com/investing/general/2016/01/12/johnson-johnsons-ceo-just-tipped-his-cap-in-a-big.aspx?source=eogyholnk0000001&utm_source=yahoo&utm_medium=feed&utm_campaign=article
The Pharmacyte Advantage:
No adverse side effects. Below see Mannkinds issues...
Afrezza has been difficult to sell because of its safety risks. The drug cannot be prescribed to patients with asthma and other serious lung ailments, according to requirements set by the Food and Drug Administration. The agency also requires doctors to test patients' lung function before writing a prescription -- and every six months during treatment.
http://www.latimes.com/business/la-fi-mannkind-ceo-20160111-story.html
Great article PL!!!!
Two key points from the article:
1. Perhaps the biggest news for shareholders though is that PMCB will be attending the 2016 JP Morgan Healthcare conference in San Francisco to meet with pharmaceutical companies and potential institutional investors. Now reading between the lines, this is a pretty big deal as it’s sponsored by JP Morgan. All the big pharma companies will be there as well as big hedge funds. It wouldn’t surprise me that we see a deal get done and PMCB either forms a joint venture or is acquired. With a current market cap of around just $58 million, PMCB would be a drop in the bucket for a firm like Merck, Pfizer, or any of the other major drug companies that would love to gets its hands on PharmaCyte’s technology.
2. Among the highlights that shareholders should look forward to this year include the Bangkok, Thailand manufacturing facility going into production. The facility is expected to receive a factory license from the Thai government any day now. This will allow the facility to produce the encapsulated cells for PharmaCyte to use in its clinical trial.
It pays to be patient...
Will Sanofi turn to PMCB now that MNKD collaberation is ended.......
- MannKind Corporation (MNKD) (MNKD) today announced the termination of its license and collaboration agreement with sanofi-aventis U.S. LLC for the development and commercialization of Afrezza® (insulin human) Inhalation Powder. The parties will promptly commence transition discussions in order to effect a smooth and orderly transition in the development and commercialization of Afrezza from Sanofi to MannKind over the next 90 – 180 days.
http://finance.yahoo.com/news/mannkind-corporation-announces-termination-license-140000447.html
Well well well....
Volume up considerably again....buyins.net has certainly been busy the last couple of weeks.
What has changed since 12/30/15?
NOTHING
How many companies the size of Pharmacyte have so many reknowned research sceintist and doctors?
How many companies the size of Pharmactye have relationships with top CRO's
How many companies the size of Pharmactye have a "drug or drug delivery system" that has already past Phase 1 and Phase 2 human clinical trials with flying colors?
How many companies the size of Pharmactye have ODD from the US and EMEA?
How many companies the size of Pharmactye have CTO's ?
How many companies the size of Pharmacyte have on going studies for both Pancreatic Cancer and Diabetes?
HOw many companies the size of Pharmactye have a schedule 1 for medical mj?
How many companies have relentless naysayers on multiple message boards?
For less than nickel you get all this and more.
2016 will be a game changing year for Pharmacyte.
Yes, totally agree that some big news is forthcoming.
I was able to add to my position today. Thank you to whomever!!!
Happy New Year to all the longs!!!!!
2016 is going to be very very interesting to say the least....
BUYINS.NET must be very busy today.....
PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell in a Box ®, announced today that BUYINS.NET, a leading provider of Regulation SHO compliance monitoring, short sale trading statistics and market integrity surveillance, has initiated coverage on Pharmacyte Biotech after releasing the latest short sale data through September 29, 2015. BUYINS.NET will monitor the market makers of PharmaCyte Biotech’s stock daily for compliance with fair market-making requirements.