Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
The question for me is why is Pharmacyte presenting their diabetes results now? They have been very tight lipped up until this meeting. Why change direction?
I wonder if Lilly, Sanofi and NovoNordisk will be attending??
Once IND is submitted Pharmactye will have a big target on their backs for takeover.....
Well,
From reading today's pr we have hired a new team......congrats!
There will be substantial preparation before the meeting with our team of new regulatory experts. They have extensive experience with the FDA in pre-IND and other meetings. We are in good hands."
Rudy,
All the companies you mentioned are very smart. Why wouldn't one of them seek a hostile takeover for "the whole kit and caboodle". They can apply enormous pressure and get Pharmactye for less than its individual parts?
I think this is a real possibility after the IND is submitted.
The scary thing is we are just in the top of the first inning....
However, once an IND is submitted pharmactye will be a major takeover target IMHO.
Congrats to all longs.....
Stocks go up and stocks go down. But eventually this stock will just keep going up...when? who knows. I cant time it but you better be in it when it happens.
We could have another quick ride up based on the house healthcare bill vote today and then their could be profit taking the day after. Just day traders.
The fact is that Pharmacyte will be meeting with the FDA very soon and the company has the top 3 pancreatic oncologists in the WORLD working with it.
It is unbelievable some people here are still questioning if this is a scam.
Another great buying opportunity!!!
Per the most recent pr, it officially stated that Dr. Von Hoff is aboard.
He would only associate himself with a winner. We will have the funding for the upcoming trial.
I have been following Pharmacyte for almost 3 years.
This is by far the best written article to date...
Not at all.
This was a serendipitous buying opportunity. There will be more of this type during the rest of the year.
Remember, Pharmacyte is a 2017 event......
Insuln cost vs Pharmacyte's potential treatment.
Below is a news clip with Lester Holt examining the high cost of insulin. Does anyone on the board have an idea if Pharmacyte's potential treatment will also be less costly?
http://www.nbcnews.com/nightly-news/video/diabetes-patients-struggle-as-insulin-costs-soar-799519811736
Pharmacyte is now a 2017 event not a 2016. Meaning that the primary goal of pc trials will now take place in 2017. When who knows.
Just relax at this point. It will happen. Disregard the MJ pumpers and other noise makers.
It is time for management to review the status of patent extentions and 2016 milestones.
1. Did management file patent extentions in September as they indicated they may have to earlier this year?
2. Below are some significant open 2016 milestones. Management needs to review each one and let us know where we stand on these. And please one conference call is not enough.
I think some of these milestones will be 2017 & 2018 milestones. Accountability is important.
Open 2016 Corporate Milestones:
Investigational New Drug Application (IND) will be filed
with the FDA following a pre IND meeting with the Company
and its representatives
Additional preclinical studies will be conducted to determine if the
Company’s pancreatic cancer treatment slows the production
and accumulation in the abdomen of malignant ascites
fluid produced by abdominalcancers, with the goal of having a
clinical trial begin by year-end or early 2017
Preclinical studies will be ongoing to test the ability of the
Melligen insulin-producing cells encapsulated using the Cell-in-aBox®
technology to treat Type 1 diabetes and insulin-dependent
Type 2 diabetes, with the goal of reaching the clinic in 2017
• Open Board of Director positons to be filled as appropriate
• PMCB will conduct shareholder calls to communicate progress
with the public as well as holding an annual shareholder meeting
Just waiting for the dilution of shares.
To get his money for trial and running the business, PMCB will need 9-12 million (6-8 million for trial, 3-4 million to keep offices and diabetes testing going).
Would not be surprised buy 1 get 2 shares free to make this deal happen.
It is going to get real ugly when the time comes. Oh the humanity of it all.
Despite all this bad news, I still believe PMCB will be successful only and I say only because of Dr. Von Huff.
Target buy out for only cancer:Oct-Nov 2017 $1-$1.25 based on level of success.
Based on the article, shareholders need to expect and accept the following:
1. I am not expecting any news until November 2016.
2. A 2017 trial start date. I am thinking now 2nd qtr 2017.
3. More extreme pain on the pps. I would not be surprised if we get to .01. Yes, unfortunately early stockholders will get screwed. A big thank you to Management. Management should have focused on the biologic issue much earlier.
4. It does matter when the trial starts. The company will burn more cash the later the start date.
Very disappointing.
Snippet from the article:
Which brings us to a final point, cash. The longer the company holds out on initiating the trial, the longer it is going to have to rely on shareholder cash injections to maintain operations. It’s got about $2 million on hand right now, and burns about $1 million every quarter. Even without the added cost of a phase IIb initiation, therefore, cash wouldn’t last too far in to 2017. As such, we’ll almost certainly see a dilutive raise between now and trial initiation.
The company has been very quiet. Maybe a little too quiet.
It's either very good news or very bad news.......a binary event so to speak.....I expect we will know in October one way or the other.
Maybe Pharmacyte's Veridis business is worth something??
https://www.yahoo.com/news/gws-cannabis-derived-drug-succeeds-third-epilepsy-study-112221073--finance.html
Third win for cannabis drug in epilepsy sends GW to record high
By Natalie Grover and Ben Hirschler,Reuters 1 hour 50 minutes ago Comments Sign in to like Reblog on Tumblr Share Tweet Email
By Natalie Grover and Ben Hirschler
(Reuters) - An experimental cannabis-derived drug has successfully treated children with severe epilepsy in a third late-stage clinical trial, sending shares in Britain's GW Pharmaceuticals to a record high on Monday.
GW, which was founded in 1998 to capitalize on the medical benefits of cannabis, said it now expected to submit a marketing application for Epidiolex to the U.S. Food and Drug Administration in the first half of 2017.
Its multiple sclerosis treatment Sativex, which is sprayed under the tongue, is already distributed by marketing partners in more than 20 countries, but not in the United States.
If Epidiolex is approved, it could become the first U.S.-approved prescription to be extracted from cannabis. It contains cannabidiol, a component of cannabis that does not make people high, and is administered as a child-friendly syrup.
Its commercial potential has attracted possible acquirers of GW, according to people familiar with the matter. Reuters reported earlier this month that GW was working with an investment bank after other drugmakers approached it to express interest in an acquisition.
Good article Brian.
As noted below from the article, management has clearly mishandled several items such as cGMP and now this Biologic issue. Still unclear with funding. As I have said extreme patience is going to be needed here. I do believe we will eventuallly be successful but with a lot of pain (lower pps).
From the article:
"One thing we have learned over the years is that time and complexity are risk points discounted by price. It is clear that the Company did not adequately prepare the market for these risk points, and they are being actively discounted now."
This reminds me of how Pharmacyte handled cGMP (not very well in my opinion).
Why was this testing not done earlier in the year or at least part of the testing done earlier? Didn't management anticipate this challenge and start earlier???? Why wasn't this dealt with in Phase 1 or 2???
I think management did tell us something today. The clinical trials will be delayed again and it looks like not until next year. My target since the conference call has been Mar/Apr assuming we get funding...
Extreme patience is going to be needed here......
Only two things matter at this time.
Getting funding for PC trials and some kind of milestone payments for diabetes. That's it. Everything else does not matter. If this happens I am confident Pharmactye will be successful with its top notch doctors.
But we need the funds to be successful......please no more meaningless pr's.
Excellent summarization.
I can only add veritas omnia vincit.
I think you are in the ballpark.
You have to add about 3-4 months to any date the CEO mentions. So the clinical start date for me is Mar/Apr 2017. I remember the cGMP fiasco......which should have been resolved in 2015.
Still believer in the treatment but must be very patient here.
I think it is going to be very quiet for August and September so I really do not expect much significant news. We are in waiting mode now.
The only wild card event that could impact the pps is the upcoming decision on medical mj by the government. Below is an interesting article on the topic....
http://anewdomain.net/2016/06/19/dea-making-prescription-cannabis-legal-across-us-report-claims-breaking/
Some constructive criticism warranted
I want to preface my comments with the fact I am a big supporter and stockowner of Pharmactye. However, some criticism is warranted:
1. The main reason we are not in phase 2B PC trials is that management keeps changing the clinical trials goals. First we were going head to head with Celgene's treatment in Australia. Next we changed the goal of the study to be consolidaton therapy comparing our treatment with the drug capecitabine plus radiation (“CRT”) in the US and Europe. Now we are changing again and going up against gemcitabine in the US and Europe. MANAGEMENT MUST STOP CHANGING THE GOALPOSTS.
2. The new PC trial design must be partially rewritten again!! and why are we still going for consolidation therapy when we are now comparing our treatment with gemcitabine. WE SHOULD BE A FRONT LINE TREATMENT NOW.
3. Why are we even talking about an Ascites trial. This should be put on temporary if not permanent hold. We do not know how much it will cost and when it will start.
4. Pharmacyte management is spending time and resources negotiating a contract with AustriaNova on Phase 3 "cannabis material". Why?? waste of time and resources.
5. Management should stop providing unrealistic trial goal dates. Just say TBD. You lose credibility when the dates are not met.The goalposts dates keep changing on both PC and Diabetes. You cannot run a business that way.
6. I am still not sure if we have the necessary funds to conduct the PC trial. It is late in the game now. We should have more certainty on this.
END
From the 10k:
I thought this was interesting. Not sure why Austrianova and Pharmacyte are negotiating a manufacturing agreement for a cannabinoid phase 3 trial when we have not even started a phase 1 or 2????
Anyone have comments or more knowledge of this??
Pursuant to the terms of the Austrianova MOU, Austrianova and we have agreed to commence negotiating during the third quarter of this calendar year a new manufacturing framework agreement pursuant to which Austrianova will provide us with Phase 3 clinical material utilizing the genetically engineered cells designed to activate cannabinoid molecules that have been encapsulated using the Cell-in-a-Box ® technology to conduct a Phase 3 clinical trial in the United States with study sites in Europe.
I do not like to speculate but let's have some fun.....
Opportunities outside the US and Europe. Hmmm maybe Japan, China, India, South Korea????
New developments: Perhaps something to do with stem cells.....
The call on Thursday should be very interesting. Don't expect every possible question to be answered. Even Exxon, GE or PG do not answer every question. There are confidentiality reasons etc.....
In the meantime, just chill and don't listen to all this noise....
Someone is getting very nervous. Lots of manipulation. Could be good fodder for a SEC investigation.
All this attention for a stock that doesn't even have a product....yet....
Well excuse the other board members. I want to wish you a Happy Birthday!
Your alias was born today........
You seem very frustrated by Pharmacyte. My recommendation is to take action as follows:
1. Send in questions for the conference call.
2. You seem to think Pharmactye is a scam. Then notify the SEC, FDA,EMEA. It is your responsibility.
Feel free to share with the board members here what you do....
Hope this makes you feel better....
I always buy quality products on sale....
I will continue to buy even if Pharmacyte's stock price declines. I believe there will be very good news from the conference call. Only makes sense. If bad news would have released already.
By the way the countdown to the conference call is now 13 days....
I think we should have a new countdown....
14 days till the conference call.....
True impact of global diabetes epidemic vastly underestimated
http://medicalxpress.com/news/2016-07-true-impact-global-diabetes-epidemic.html
A landmark paper led by Monash University with partners in the UK and US suggests there may be more than 100 million people with diabetes globally than previously thought. The prevalence of global diabetes has been seriously underestimated by at least 25 per cent, according to the paper published on Saturday 9 July 2016 in Nature Reviews. In 2015, the official International Diabetes Federation (IDF) estimated the number of people with diabetes was 415 million, however the actual number may be as high as 520 million
I also believe that something big is imminent. I have been accumulating shares at these low prices for weeks.
The article yesterday using the phrase "artificial liver" caught my attention. This term was never used before. There must be more to CIAB than we think.
I also believe as I said before that the medical MJ government decision looming could propel Pharmacytes' stock price.
Feeling great about my ownership
The MM's are forcing me to buy more. Thank you......
An unexpected "wild card" event could impact Pharmacyte in the coming weeks.
While I believe Pharmacyte is not in the medical MJ business per se, this ruling could have a short term positive impact on the pps.
http://www.foxbusiness.com/markets/2016/06/25/arguably-most-important-marijuana-decision-ever-is-just-weeks-away.html
This marijuana decision could be a game-changer
Sometime within the next couple of weeks, the U.S DEA is expected to rule on whether or not it will reschedule marijuana away from its current schedule 1 classification. If the regulatory agency were to reclassify marijuana as anything other than a schedule 1 substance, then medical marijuana would immediately become legal throughout the U.S., thus opening the door for medical marijuana businesses to prosper. It would also remove those aforementioned disadvantages holding the industry back.
The U.S. Food and Drug Administration has already submitted its recommendation on marijuana's scheduling to the DEA. However, DEA administrator Chuck Rosenberg has been tight-lipped as to what that recommendation was. The DEA is in the process of conducting its own eight-factor analysis, according to Inc.com, which will help the regulatory agency decipher what sort of abuse potential cannabis may possess.
There are, of course, a variety of options for the DEA to choose. It could completely deschedule marijuana, putting the plant on par with tobacco and alcohol. It could also choose to place a scheduling ranging from 2 through 5 on the substance. Drugs scheduled between 2 and 5 are deemed to have medical benefits, but as you get closer to schedule 2 (moving up the scale from schedule 5), the drug's perceived addictiveness increases. Finally, certain substances within cannabis could be legalized, while the plant itself could remain illegal. The DEA has plenty of options.
Health insurer’s limit on insulin pumps worries patients
Just another reason why Pharmacyte's diabetes treatment is needed now
The article says:
Starting July 1, customers on many of UnitedHealth’s plans will only be able to choose between two Medtronic pumps or an option made by Insulet Corp. If patients want another brand, they may have to pay some or all of the cost. The insurer says it will make exceptions for patients who have a medical need for another option.
These systems can cost $5,000 or more, plus supplies.
Rodenberg-Lewis had used a Medtronic pump for 15 years before switching to one made by Animas Corp. She didn’t think the Medtronic monitor was accurate enough, and she said the pump’s supplies, which are not fully covered by insurance, were more expensive. The pump also wasn’t waterproof, a key feature for someone who frequents pools and water parks during blazing hot Texas summers.
http://www.seattletimes.com/business/health-insurers-limit-on-insulin-pumps-worries-patients-2/
Lipitor was one product and its sales reached $13 billion in a year and have totalled 141 billion over its life.
Just saying.......
Uboat,
IMO, MJ will never come in to play for Pharmacyte. The company's focus is on cancer and diabetes.
Did you listen to the interview posted the other day. The real takeaway for me is that a clinical date for PC will be announced within 2/3 weeks (not sure from date of interview on June 2 or the date of release of the interview June 20th).
If you read into this, I would assume they have met with the FDA and are waiting for their approval. Otherwise, how can you set a date? This is very good news. So just be a little more patient......I feel your pain...
I liked the interview but left wanting more ie IND? exact date pc clinical?
why name change of CIAB (notice no mention of this term in discussion),any partnerships esp with diabetes......
Two takeaways:
1. Clinical trial dates to be announced either 2 or 3 weeks from date of interview (June 2) or from today's news release?? Still not sure but sounds like Good news!!!
2. Diabetes human clinicals starting late 4th qtr 2017....I am sure they have made tremendous progress but they have also not met one date on PC trials for legit or not legit reasons so I dont believe this date. Probably more like 2018...
Mixed bag today...but slightly positive...
Pharmacyte management has indicated in the past that there may be refinements to their PC clinical trial (see prior announcements).
Apparently this meeting ended up being a working session and the input from other oncologists can only be helpful. No one person has all the answers so this does not concern me at all. Actutally I like it...
They have already announced the delay of the PC trial to the 4th qtr of 2016. Disappointing yes but rather get it right than rush at this juncture.
My key takeaway from the recent meeting is this:
We have attracted considerable interest of late in the biotech sector and plan to capitalize on this while here in San Francisco. We have a golden opportunity for the world to learn more about PharmaCyte’s novel therapies for cancer and diabetes than ever before, and to learn why we believe they will have such a positive impact on patients who suffer from these dreadful diseases.”
I missed the live web by KW. Can someone summarize? Any new developments?
TIA
Pharma sector set for wave of mergers, acquisitions: study
https://www.yahoo.com/news/pharma-sector-set-wave-mergers-acquisitions-study-130513684.html
Frankfurt (AFP) - The pharmaceuticals sector is facing an intensive period of mergers and acquisitions in the coming years, even if US firms Pfizer and Allergan recently failed to tie the knot, the corporate consultancy firm EY said Monday.
"We're going to see a high level of investments and divestments in the pharmaceuticals sector in the coming years," said Gerd Stuerz, analyst at EY.
In April, Pfizer and Allergan called off a $160-billion (144-billion-euro) tie-up to create a new world leader in pharmaceuticals ahead of Switzerland's Novartis due to a US crackdown on tax-saving mergers.
But that is unlikely to signify the end of a wave of major deals in the sector, EY said.
"Companies will sell off entire divisions or buy new ones in order to strengthen their position," said another expert Siegfried Bialojan.
In face of fierce competition, external growth is now key for many companies.
"Pharmaceutical groups can only present innovations quickly if they buy these from outside," Bialojan argued.