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Not only has he not list credibility, but Dr Von Hoff was named as "2015 Researcher of the Year" by AZ Business magazine. :)
http://www.eurekalert.org/pub_releases/2015-04/ttgr-abm041015.php
AZ Business magazine picks TGen's Dr. Daniel D. Von Hoff as 2015 Researcher of the Year
Dr. Von Hoff directs clinical trials, translating research discoveries into new treatments for patients
THE TRANSLATIONAL GENOMICS RESEARCH INSTITUTE
PHOENIX, Ariz. -- April 10, 2015 -- AZ Business magazine has named Dr. Daniel D. Von Hoff of the Translational Genomics Research Institute (TGen) as its 2015 Researcher of the Year.
The magazine -- part of AZ Big Media, which is celebrating "30 Years of Excellence" -- announced Dr. Von Hoff's recognition at its Healthcare Leadership Awards dinner April 9 in Phoenix.
Dr. Von Hoff, M.D., TGen's Distinguished Professor and Physician-In-Chief, directs clinical trials at the Virginia G. Piper Cancer Center Clinical Trials at HonorHealth that translates TGen research discoveries into new treatments for patients.
"I am honored to be named AZ Business magazine's Researcher of the Year, especially in light of the other fine physician-scientists nominated," said Dr. Von Hoff. "Our work in translation of laboratory discoveries into clinical trials is vitally important for the many patients who we all strive to help."
Others nominated for the magazine's Researcher of the Year were: Dr. Glen Weiss, M.D., of Cancer Treatment Centers of America (CTCA) at Western Regional Medical Center (Western) in Goodyear, Ariz.; Dr. David Jacofsky, M.D., Chairman of The CORE Institute.
Keynote speaker at the event was Dr. Connie Mariano, former White House Physician to the President and first woman Director of the White House Medical Unit, whose new book is titled The White House Doctor: My Patients were Presidents.
Also honored at the event for a Lifetime Achievement Award was Peter Fine, President and CEO of Banner Health, and a former executive with health systems in Wisconsin, Illinois and Indiana.
http://www.eurekalert.org/pub_releases/2015-04/ttgr-abm041015.php
I totally agree... I guess they did get a small pop. I heard someone say they made an 8% profit from Friday until today.
In the end, believers will benefit the most, imo. Not only will we realize our profits, but we will also enjoy trial milestones. It will be best when we can hear about how CiaB technology is improving the "quality of life" and curing diseases for many people. I will also be happy for all our lead players. They are working very hard to help all stakeholders achieve the above objectives.
Good to hear from you, btw. :)
I missed that. Good catch... Why would a company pay for articles over which they have no editorial control? Counterintuitive for sure...
PMCB already told us that trials won't start until cGMP so this misinformation just goes to show PMCB did not back or pay for this release.
Happy to...
PharmaCyte Seeks to Solve Pancreas Puzzle with Cell-in-a-Box
Considering its relatively inconspicuous presence in the body, the pancreas can wreak havoc on human health through two major diseases: diabetes and pancreatic cancer. Both can be deadly – the former from the condition itself or from long-term complications and the latter from advanced disease that may be symptomatic for only months or even weeks. Neither has a cure.
Pharmacyte Biotech Inc. aspires to change that bleak prognosis with a technology that can attack both culprits. The Silver Spring, Md.-based company was founded in 1996 as Efood Systems, which tracked the movement of refrigerated trucks, before morphing into a natural products firm and eventually changing its name to Nuvilex Inc. In early 2011, the company established a relationship with the inventors of an unusual encapsulation technology with the idea of moving into nutraceuticals.
Poor financial decisions nearly derailed the company, which restructured again last year, assembling a new leadership team and taking direct aim at the biotech market with the live cell encapsulation platform, known as Cell-in-a-Box. Ken Waggoner, president, CEO and chairman of Pharmacyte, said the team “brought the technology back from the dead” and is eager to see the platform to fruition in multiple therapeutic applications.
Cell-in-a-Box technology involves the encapsulation of living cells in protective “cocoons” – capsules that are visible to the eye at about the size of the head of a pin. The capsules prevent the cells from escaping into the body while keeping the immune system from invading.
The multi-step encapsulation process begins with the suspension of the live cells in a medium that contains a polymer and sodium cellulose sulfate. That suspension is passed through specialized equipment to form droplets, which fall into a solution containing a second polymer. When the polymers interact, a membrane forms around each droplet, ultimately developing into the protective shell.
An important distinction between the capsules produced through Cell-in-a-Box technology and those fabricated by potential competitors is Pharmacyte’s use of cellulose – a bioinert material that doesn’t prompt an immune system response – rather than substances such as the seaweed derivative alginate or chitosan.
“The Cell-in-a-Box capsules can withstand various external forces, unlike those made using other encapsulation methods,” Waggoner said, enabling Pharmacyte’s capsules to be implanted intact using needles or catheters. “Our capsules don’t degrade, even after being present in the body for over two years, and they don’t cause damage to, or inflammation of, nearby tissues in the body.”
In the lead pancreatic cancer indication, approximately 300 Cell-in-a-Box capsules that each contain some 10,000 cytochrome P450-expressing cells are placed as close as possible to the tumor site, then one-third the normal dose of the chemotherapeutic ifosfamide is injected systemically. When the capsules and the chemotherapeutic come into contact, the encapsulated cells convert ifosfamide at the site of the tumor, providing a high concentration of the cancer-killing agent without the traditional side effects of high-dose chemotherapy.
Pharmacyte acquired exclusive global rights to the technology from Austrianova Singapore Pte. Ltd., of Singapore, in all cancer indications and in diabetes and also holds rights to use cancer prodrug-activating cells as part of the treatment protocol for advanced pancreatic and other cancers. The Cellin-a-Box capsules are produced in a cGMP-compliant facility managed by
Pharmacyte is preparing to conduct a phase IIb trial in patients with borderline operable or non-operable pancreatic cancer, expected to begin in the third quarter, that will compare its treatment head-to-head with gemcitabine combined with Abraxane (nab-paclitaxel, Celgene Corp.). In July, the company initiated a second preclinical study in mice to assess the effectiveness of its pancreatic cancer treatment on the rate of accumulation of malignant ascites fluid in pancreatic cancer and other abdominal tumors, testing four separate doses of ifosfamide with the goal of setting parameters for the design of a phase I. Pharmacyte plans to conduct a separate trial, also beginning this quarter, to investigate the role of Cell-in-the-Box in reducing pain associated with tumor growth.
Last year, the FDA granted orphan drug designation to the company’s pancreatic cancer treatment.
In addition to pancreatic cancer, data from an early trial suggested the Cell-in-a-Box technology might have an effect on downstream micro metastatic disease, which could apply to other tumor types. Pharmacyte has initiated preclinical programs in brain and breast cancer, using cannabinoid prodrugs in combination with Cell-in-a-Box. Last month, the University of Northern Colorado, one of the company’s research partners, obtained a Schedule 1 license from the Drug Enforcement Agency, enabling it to begin experiments using cannabinoids.
‘WE THINK WE HAVE A SHOT AT CURING DIABETES’
For treatment of type 1 and insulin-dependent type 2 diabetes, Pharmacyte uses the same Cell-in-a-Box technology but with Melligen cells – a human liver cell line genetically modified to produce insulin on demand that was developed by researchers at University of Technology Sydney, Australia – rather than the more common pancreatic beta-islet cells to serve as a bioartificial pancreas.
“A lot of companies are trying to do this type of technology with different types of cell encapsulation and different types of devices,” said Gerald Crabtree, Pharmacyte’s chief operating officer. “Nearly all of them are centered around some form of islet cell, but islet cells are notoriously difficult to keep alive for long periods in the body, even if they’re encapsulated.”
The Melligen cells “are easier to keep alive, and that’s the key,” he added. Pharmacyte holds the exclusive worldwide license to the cell line. Preclinical testing of the diabetes approach is under way through an international consortium the company recently spearheaded.
Although questions about the diabetes indication remain – exactly where to place the capsules in insulin-dependent patients, for instance – “we think we have a shot at curing diabetes,” Waggoner said. “We certainly know we can reverse the condition.”
Of course, the technology first needs to succeed in human studies, and that will take a few years.
“We believe we’ll be able to get into the clinic much sooner than anyone would have anticipated when we started down this path,” Waggoner said. Outside experts predicted the company would need more than five years to move the diabetes program, initiated in April 2014, into clinical trials, but Waggoner is confident that timetable can be truncated to 2017 – perhaps earlier. And, since the pancreatic cancer work is already under way, “by the time we get into the clinic with diabetes, the FDA will know this technology platform,” he pointed out.
In addition to establishing the diabetes consortium, Pharmacyte has been meeting with investors and clinical investigators and conducting road shows in New York, Boston and the Bay Area to “test drive” its message. The company also had a busy dance card at the BIO International Convention in Philadelphia, where it hosted dozens of meetings at its suite in the Ritz-Carlton Hotel.
For the time being, Pharmacyte is comfortably financed through a $50 million at-the-market facility. But with the prospect of large trials looming down the road, the company also is assessing the interest of big pharmas, and many have signed nondisclosure agreements.
“We’ve been approached by a number of people who want to get involved,” Waggoner said. “They’ve recognized that our treatment is very different from any approach that’s out there.”
Yes, they can purchase Cell in a Box and use it with their own drugs in preclinical studies but going further would infringe on "third party rights" (PMCB).
"Legal Information
(a)This product shall only be used for research purposes. Purchaser shall not use the product to manufacture commercial products and/or to sell services relating to or using the product.
(b) Sigma Aldrich does not grant to purchaser any license, express or implied, in violation of or infringing upon any third party rights. Purchaser is responsible for determining the existence of any such third party rights and to acquire any such rights, should they exist, before using the product.
(c) Purchaser acknowledges and agrees that the product is not intended for use in humans, and agrees not to conduct research with it in humans."
And it was our CEO who said we have NDAs...
"But with the prospect of large trials looming down the road, the company also is assessing the interest of big pharmas, and many have signed nondisclosure agreements. " Ken Waggoner
http://www.bioworld.com/content/pharmacyte-seeks-solve-pancreas-puzzle-cell-box
That is just sad...
"But with the prospect of large trials looming down the road, the company also is assessing the interest of big pharmas, and many have signed nondisclosure agreements. "
http://www.bioworld.com/content/pharmacyte-seeks-solve-pancreas-puzzle-cell-box
This is what I do know. 1Q2016 is 5 months away, not 9. A plan is not a promise and the company has always been forthright about needing to be GMP compliant prior to starting any trials.
Most recent update...
"Our plans are to begin the clinical trials by the fourth quarter of 2015 and possibly sooner, but the start date for the clinical trials will depend upon regulatory approval of Austrianova’s cGMP encapsulation facility in Bangkok, Thailand. That is the facility where our genetically modified living cells will be encapsulated using the Cell-in-a-Box® technology.”
http://www.pharmacytebiotech.com/chardan-releases-industry-report-covering-pharmacyte-biotech/
And from 2013.. Getting GMP approval has always been understood as a requirement to starting trials.
"Completing the GMP facility construction and establishing GMP standards for production of the encapsulated cells that are part of its pancreatic cancer treatment should serve as a catalyst for the Company and bring Nuvilex one step closer to advanced clinical trials."
http://www.marketwatch.com/story/establishing-a-good-manufacturing-practices-facility-serves-as-a-catalyst-for-nuvilex-2013-09-13
Gotcha. Well, we do know that MMs manipulate and R&Ds dilute, so I imagine it's a little of both. Bottom-line, value still to be realized. Ignore the current pps... It's not time to cash in yet. The game is not over yet...
“Games are won by players who focus on the playing field –- not by those whose eyes are glued to the scoreboard.”
Warren Buffett
OTC Biotech investment 101. Longs know the risks but we have also determined that, for us, the potential rewards outweigh the risks. Ours is a math of valuation that has not been achieved yet. IMO, the value of CiaB technology, when proven, will still add up to multiple dollars which makes dilution for me, less of a concern...
Keay Nakae said The following in an interview. He also gave us a 70% buy rating...
TLSR: I'm going to ask this next question specifically because you follow both micro-cap and small-cap stocks. Micro-cap names may not be very reactive to catalysts, even though the catalysts might be very positive. Many micro-cap biotech and specialty pharma stocks have significantly lagged this two-year biotech bull market. I'm wondering if you can venture an opinion as to why these micro caps are not following the lead of small-, mid- and large-cap biotech stocks.
KN: The lag time has to do with both the micro caps' investor base, and also with what their future funding requirements are going to be.
Let's say you have a company working on a product, and let's say it has some positive preclinical data. The developer is still going to have to go through phase 1, phase 2 and phase 3 studies, so we know the pathway required to get that drug approved. But at step one the developer is still a long way off, and there is a lot of work that needs to be funded. The market knows that the company is going to need additional capital. In most cases it is too early to talk about partnering at this stage, so the developer has to go it alone. Hence, the need at some point to raise additional cash, which means further dilution, which represents an overhang on the stock.
http://www.pharmacytebiotech.com/wp-content/uploads/2015/08/Chardan-Capital-Analyst-Report-2015-08-03.pdf
http://wire.kapitall.com/investment-idea/four-small-cap-growth-names-different-value-drivers-keay-nakae/
Great post with a lot of good information. The thing I did pick up on is that " Austrianova is in the process of building upon its GMP knowledge by establishing larger scale GMP manufacturing in S.E. Asia."
"Larger scale manufacturing" is the current goal and it is good to know they have the experience under their belt to get them there.
http://austrianova.com/manufacturing/
Absolutely but patience is not something most can practice. Yet, it is absolutely required when investing in a biotech. PMCB has been a biotech for only a couple of years now. Some have not been able to adjust to the change...
LMAO, 1+1 does not = 3.
The potential upside is worth the risk for me. This technology is worth billions with treatments for all abdominal cancers and a possible CURE for diabetes. Long term holders have the best chance for realizing the greatest value, IMO.
Well said. :)
Reckless, how so? We all just have to wait for GMP approval but we also have to be prepared to start trials as soon as we have the green light. Our management team has to set things in motion to be ready and shareholders have a right to be in the loop. This is a long term hold for me. I am in no rush so I really don't understand how it's reckless. We have known all along we need GMP, so now we wait and be ready for trials when approved.
No worries...
Says who? LOL! Haven't heard that anywhere before and the video is out there for everyone to see.... Names and corporate positions all there for anyone to contest. Don't hear anyone of import crying foul.
Absolutely, LMAO!
“We’ve been approached by a number of people who want to get involved,” Waggoner said. “They’ve recognized that our treatment is very different from any approach that’s out there.”
PharmaCyte Seeks to Solve Pancreas Puzzle with Cell-in-a-Box
Considering its relatively inconspicuous presence in the body, the pancreas can wreak havoc on human health through two major diseases: diabetes and pancreatic cancer. Both can be deadly – the former from the condition itself or from long-term complications and the latter from advanced disease that may be symptomatic for only months or even weeks. Neither has a cure.
Pharmacyte Biotech Inc. aspires to change that bleak prognosis with a technology that can attack both culprits. The Silver Spring, Md.-based company was founded in 1996 as Efood Systems, which tracked the movement of refrigerated trucks, before morphing into a natural products firm and eventually changing its name to Nuvilex Inc. In early 2011, the company established a relationship with the inventors of an unusual encapsulation technology with the idea of moving into nutraceuticals.
Poor financial decisions nearly derailed the company, which restructured again last year, assembling a new leadership team and taking direct aim at the biotech market with the live cell encapsulation platform, known as Cell-in-a-Box. Ken Waggoner, president, CEO and chairman of Pharmacyte, said the team “brought the technology back from the dead” and is eager to see the platform to fruition in multiple therapeutic applications.
Cell-in-a-Box technology involves the encapsulation of living cells in protective “cocoons” – capsules that are visible to the eye at about the size of the head of a pin. The capsules prevent the cells from escaping into the body while keeping the immune system from invading.
The multi-step encapsulation process begins with the suspension of the live cells in a medium that contains a polymer and sodium cellulose sulfate. That suspension is passed through specialized equipment to form droplets, which fall into a solution containing a second polymer. When the polymers interact, a membrane forms around each droplet, ultimately developing into the protective shell.
An important distinction between the capsules produced through Cell-in-a-Box technology and those fabricated by potential competitors is Pharmacyte’s use of cellulose – a bioinert material that doesn’t prompt an immune system response – rather than substances such as the seaweed derivative alginate or chitosan.
“The Cell-in-a-Box capsules can withstand various external forces, unlike those made using other encapsulation methods,” Waggoner said, enabling Pharmacyte’s capsules to be implanted intact using needles or catheters. “Our capsules don’t degrade, even after being present in the body for over two years, and they don’t cause damage to, or inflammation of, nearby tissues in the body.”
In the lead pancreatic cancer indication, approximately 300 Cell-in-a-Box capsules that each contain some 10,000 cytochrome P450-expressing cells are placed as close as possible to the tumor site, then one-third the normal dose of the chemotherapeutic ifosfamide is injected systemically. When the capsules and the chemotherapeutic come into contact, the encapsulated cells convert ifosfamide at the site of the tumor, providing a high concentration of the cancer-killing agent without the traditional side effects of high-dose chemotherapy.
Pharmacyte acquired exclusive global rights to the technology from Austrianova Singapore Pte. Ltd., of Singapore, in all cancer indications and in diabetes and also holds rights to use cancer prodrug-activating cells as part of the treatment protocol for advanced pancreatic and other cancers. The Cellin-a-Box capsules are produced in a cGMP-compliant facility managed by
Pharmacyte is preparing to conduct a phase IIb trial in patients with borderline operable or non-operable pancreatic cancer, expected to begin in the third quarter, that will compare its treatment head-to-head with gemcitabine combined with Abraxane (nab-paclitaxel, Celgene Corp.). In July, the company initiated a second preclinical study in mice to assess the effectiveness of its pancreatic cancer treatment on the rate of accumulation of malignant ascites fluid in pancreatic cancer and other abdominal tumors, testing four separate doses of ifosfamide with the goal of setting parameters for the design of a phase I. Pharmacyte plans to conduct a separate trial, also beginning this quarter, to investigate the role of Cell-in-the-Box in reducing pain associated with tumor growth.
Last year, the FDA granted orphan drug designation to the company’s pancreatic cancer treatment.
In addition to pancreatic cancer, data from an early trial suggested the Cell-in-a-Box technology might have an effect on downstream micro metastatic disease, which could apply to other tumor types. Pharmacyte has initiated preclinical programs in brain and breast cancer, using cannabinoid prodrugs in combination with Cell-in-a-Box. Last month, the University of Northern Colorado, one of the company’s research partners, obtained a Schedule 1 license from the Drug Enforcement Agency, enabling it to begin experiments using cannabinoids.
‘WE THINK WE HAVE A SHOT AT CURING DIABETES’
For treatment of type 1 and insulin-dependent type 2 diabetes, Pharmacyte uses the same Cell-in-a-Box technology but with Melligen cells – a human liver cell line genetically modified to produce insulin on demand that was developed by researchers at University of Technology Sydney, Australia – rather than the more common pancreatic beta-islet cells to serve as a bioartificial pancreas.
“A lot of companies are trying to do this type of technology with different types of cell encapsulation and different types of devices,” said Gerald Crabtree, Pharmacyte’s chief operating officer. “Nearly all of them are centered around some form of islet cell, but islet cells are notoriously difficult to keep alive for long periods in the body, even if they’re encapsulated.”
The Melligen cells “are easier to keep alive, and that’s the key,” he added. Pharmacyte holds the exclusive worldwide license to the cell line. Preclinical testing of the diabetes approach is under way through an international consortium the company recently spearheaded.
Although questions about the diabetes indication remain – exactly where to place the capsules in insulin-dependent patients, for instance – “we think we have a shot at curing diabetes,” Waggoner said. “We certainly know we can reverse the condition.”
Of course, the technology first needs to succeed in human studies, and that will take a few years.
“We believe we’ll be able to get into the clinic much sooner than anyone would have anticipated when we started down this path,” Waggoner said. Outside experts predicted the company would need more than five years to move the diabetes program, initiated in April 2014, into clinical trials, but Waggoner is confident that timetable can be truncated to 2017 – perhaps earlier. And, since the pancreatic cancer work is already under way, “by the time we get into the clinic with diabetes, the FDA will know this technology platform,” he pointed out.
In addition to establishing the diabetes consortium, Pharmacyte has been meeting with investors and clinical investigators and conducting road shows in New York, Boston and the Bay Area to “test drive” its message. The company also had a busy dance card at the BIO International Convention in Philadelphia, where it hosted dozens of meetings at its suite in the Ritz-Carlton Hotel.
For the time being, Pharmacyte is comfortably financed through a $50 million at-the-market facility. But with the prospect of large trials looming down the road, the company also is assessing the interest of big pharmas, and many have signed nondisclosure agreements.
“We’ve been approached by a number of people who want to get involved,” Waggoner said. “They’ve recognized that our treatment is very different from any approach that’s out there.”
http://www.bioworld.com/content/pharmacyte-seeks-solve-pancreas-puzzle-cell-box
It is simply to be expected in a biotech. There was no special wisdom required to make that guess. And it is possible they will start before 2016, just waiting on GMP.
And those trial results have been publicly communicated with no one of import disputing them. I will follow those who are in the know, not sideliners...
Seriously? It is audacious to have a plan? It would be imprudent to not have a plan for trials. Everyone knows that things don't always go as planned. And most don't have a problem with that as long as delays are explained and new plan dates targeted. I appreciate that our CEO keeps us informed...
All stakeholders need to know what to expect.
Of course we knew it was a possibility. Everything is dependent on GMP approval for Austrianova's Thai facility. Everyone knows that and the company has always been forthright about it. I do wish I understood the process more to get a better feel for the steps in the process and where Austrianova is in the process. I am not in a rush. This is long term for me so I will wait it out. The upside on this is huge.
Mr. Nakae has only started working for Chardan in January of this year and has over 15 years of experience as a research analyst.
"It's important to take the emotion out of investing. Keay Nakae, senior research analyst with Ascendiant Capital Markets, looks at micro- and small-cap biotech stocks from an engineer's perspective: It's all about the data."
Read more: http://www.nasdaq.com/article/four-smallcap-growth-names-with-different-value-drivers-keay-nakae-cm279110#ixzz3hrKwajMV
What failed trials? All trials associated with PMCB have been successful. From where did you hear about failed trials?
Here is what we know so far from the recent trials with TD2...
"Preliminary data analysis suggests that treatment with PharmaCyte Biotech’s live-cell encapsulation technology, Cell-in-a-Box(R) plus ifosfamide, produces a significant survival advantage as compared to non-treated control animals. PharmaCyte Biotech’s treatment appears to be at least as good as cisplatin, the current standard of care for ovarian cancer. However, when the encapsulated cells plus ifosfamide were used in conjunction with cisplatin, the survival rate was greatly enhanced."
http://www.pharmacytebiotech.com/nuvilex-announces-preliminary-data-preclinical-study-effects-pancreatic-cancer-treatment-ascites-fluid-formation/
"The analyst(s) responsible for covering the securities in this report receives compensation based upon, among other factors, the overall profitability of Chardan Capital Markets including profits derived from investment banking revenue and securities trading and market making revenue. The analyst(s) that prepared the research report did not receive any compensation from the Company or any other companies mentioned in this report in connection with the preparation of this report."
He is paid by Chardan, not by anyone from the company... It is good to see this report which is being shared with the big players...
"Our plans are to begin the clinical trials by the fourth quarter of 2015 and possibly sooner, but the start date for the clinical trials will depend upon regulatory approval of Austrianova’s cGMP encapsulation facility in Bangkok, Thailand. That is the facility where our genetically modified living cells will be encapsulated using the Cell-in-a-Box® technology.”
BTW, this is a report done by a major financial institution and it goes out to other institutional investors. And we were given a buy distribution rating of over 70%.
No need to worry Mens et Manus. Ca va bien. The countdown to rush the process is only being done to create a panic. The professionals are not concerned about getting GMP. We should not be either. All we need is to be patient. :)
Happy Monday, all! I like the way we have been trading since AST took over. :)
Don't do it yet. Still doing dd. Bi have some concerns. Need to follow them a while.
Sounds good to me Rudy. I just hope we don't sell diabetes or cannabinoids. That would definitely be a win win.
Yes, the studies for ascites are currently undergoing a second follow up study. I don't know if we will get formal results from TD2 for the preclinicals or not. But the company had told us the results have been positive. That and the fact that we are still planning on starting Phase 1 later this year lead me to believe all is going as expected.
Thanks for the update rcstock. I figured TD2 may be the driver of reporting results. They are certainly not concerned with affecting the pps. Their concern, as medical professionals, is to provide the best chance for helping patients. I am happy to let them focus on getting the treatment as close to perfection as possible. Ultimately, its a win/win for all.
jz, every time I consider diversifying, I can never find another investment with so much potential as PharmaCyte Biotech. For me, the most important thing is GMP approval. I don't doubt that we will get it because our product has been housed in other GMP facilities and whatever changes need to be made will be done for compliance.
But we need the approval to move forward with human trials. We have been advised that results from the trials with TD2 were positive and we know that Dr Von Hoff is very familiar with FDA requirements. I am sure he is just dotting all the i's and crossing all the t's. Once we get GMP for our Thailand Facility, we will have accomplished a major milestone and will be one step closer to helping patients and patience. :)
Have a good weekend!
So true Bio. For example, longs look at PRs as information on how and what the company is doing. Flippers hope PRs will drive the pps up for a moment so they can flip for a small profit. They are always surprised when we don't care that a PR has not impacted the pps. In the long term, each bit of information we get about what we are doing to progress our technology, will eventually affect the value here.
"Patients and patience will be rewarded."
i am not the least bit discouraged. If I was driven by current pps, I'd have left a long time ago. I pay attention to a lot more than the current pps. We are building a major biotech here. It takes time. Only those with vision and patience will be rewarded.
Great post, thanks.
Thanks, I will do much more DD here.