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Sounds good to me... Haha...
I think you are right. He may have to be replaced on the board...
Another step in the process completed... moving forward...
Good news. We have our PI. After being an investor for over 2 years, I am not shaken by delays of any kind. KW delivers from my experience and it is all worth the wait, imo....
"This novel technology has exceedingly broad application." Dr. Hidalgo
If I see KW has been busy with preparing good news, my belief is a conference call will follow. It makes sense to wait until after a big update to have the call.
I felt the same way but with all this volume it makes me think this one man crew may be pretty busy. Some things may be happening behind the scenes. All will be forgiven with some good news. :)
Great post!
I will. Thanks for the update. I appreciate your commitment. GLTU
Hey Blane. Hope all is well. Good to see you holding up the fort...
No wonder it's so quiet here today... 3.5 million thus far? Hmm...
How did I miss that? Thanks for the post...
Why thank you PL... Enjoy your weekend.
$Pistol Pete$!
Amen to that!
Wow, thanks Brian. When I saw this technology it was so easy to understand how it works and if it can do what it has done in the past, that would make all the waiting worthwhile.
The good news is that since Dr Von Hoff showed interest, the company believes CiaB is capable of much more. Happy to be on this journey with so many, including you... Many of whom were here long before us. I think the technology is well worth the risk.
So true...
Who said today was going to be red?
I concur... But there is money to be made here and quality of life improvements for many. There are some very wealthy philanthropists out there. It is possible to get around big pharma or partner with them. If trials go well, I think either of the aforementioned is very possible.
Tells me, no one has a crystal ball... :)
Sweet...
I concur... Only invest what you can afford. Single company stocks are risky. But sometimes it takes a risk to accomplish great things...
So then you know the hold up after reading the most recent PR. Single stock investments are risky especially on the OTC. They are also an easy target for those wanting to profit off of a vulnerable company. There is someone here who proudly shouts how much they love to short this stock and has been doing it for years.
With that said, I will follow the lead of the doctors and other professionals who are waiting patiently for us to get to trials. I don't have a crystal ball and don't know anyone who does but what I do have is belief in the technology and all those supporting its potential.
I would never consider doing any less...
Yeah, Bio put this together a couple of months ago. I restickied it too. So easy to dismiss all that's been done -so it's important to keep record of it.
"We understand that shareholders are frustrated with our current share price; however, the share price doesn’t reflect where PharmaCyte is today. In what has been a relatively short time for a biotech company, we have dramatically moved our Cell-in-a-Box® technology forward along the path toward the clinic, we have surrounded our technology with some of the best minds in the industry and we have put together a team that is working diligently every single day to get PharmaCyte in front of the U.S. Food and Drug Administration (FDA) so that we can clear the final hurdles that will allow us to begin our clinical trial in advanced pancreatic cancer. There are numerous moving parts on many fronts. Just because our shareholders aren’t seeing news on a weekly basis, this does not mean there isn’t a flurry of work being done every single day.
“It is important for our shareholders to realize that PharmaCyte’s pancreatic cancer therapy is classified by drug regulatory authorities as a ‘biologic’ rather than a single molecule drug or a New Chemical Entity (NCE). This is because our therapy involves the use of living, genetically altered human cells. The overall development process is much more involved and more complex for a biologic than an NCE. Nevertheless, PharmaCyte’s therapy is moving forward at a realistic pace. Our partner Austrianova will be carrying out an engineering manufacturing ‘run’ in the near future of the production of the capsules that will be used with low dose ifosfamide as our pancreatic cancer therapy. If successful, not only will this run define the specifications of the capsules that will be use to encapsulate the living cells, it will also set the stage for cGMP production of the capsules for our planned clinical trial.
“An example of the different environment that we’re working in is that biologic products – particularly encapsulated living cell products like PharmaCyte’s and unlike most pharmaceutical products which can be simply ‘end-sterilized’ and delivered as sterile products – must be kept alive from the moment the cells are thawed from the frozen research cell bank and then encapsulated until they are implanted in a patient. At all times during these operations our product must be kept free of contamination by bacteria, yeast and fungi. Thus our biologic product is more akin to a live vaccine or to a stem cell therapy. The cell culture medium used to maintain the living cells within the capsules is also an excellent growth medium for all of those previously mentioned undesirable contaminants. Contaminant and other testing of our research cell bank is underway at ViruSure, one of PharmaCyte’s contractors, while Austrianova continues to make steady progress in order to manufacture cGMP clinical trial material that we will need to begin the trial.
“It goes without saying that great care has to be taken at every step to ensure the maintenance of aseptic conditions; this is one reason for carrying the production out in an ‘isolator’ that prevents actual contact between production staff and the product being manufactured. A living cell product also brings with it new regulatory challenges. PharmaCyte has been steadily working through these challenges with a number of regulatory advisors both in the United States and in the United Kingdom. These exciting new “Advanced Medicinal Products” are the future of treatment for serious diseases, and in many ways pioneering companies, like PharmaCyte, are working with the regulators to lay the ground work for tomorrow’s regulatory framework.”
http://pharmacyte.com/pharmacytes-ceo-discusses-development-of-its-pancreatic-cancer-therapy/
Here is a very nice list of accomplishments...
PMCB - On target for Phase IIB clinical trial and has destroyed all of the hurdles required to get to this point. Read the breakdown below for the things Ken Waggoner (KW) has completed in just over 2 years. First he had to fix the pile of garbage he was left with. A company with a product and no clue how to get it into trials. That alone takes time. KW made quick work of that and then did all of this leading up to today. The following will show that PMCB is not a scam and it has been moving forward towards clinical trials since KW walked in the door.
1-1-14 - KW officially takes over as President of NVLX
1-30-14 - NVLX immediately acquires 14.5% equity interest in Austrianova. First vision
3-20-14 - NVLX contracts with Austrianova to encapsulate cells for clinical trials.
4-1-14 - NVLX selects TD2 to conduct preclinical and clinical studies. i.e. the mice studies-
In 3 shorts months the relationship with Austrianova is solidified and the relationship with TD2 begins.
5-1-14 - NVLX and PMCB begin preclinical studies
7-9-14 - NVLX begins studies for treatment of Ascites Fluid
8-20-14 - TD2 joins NVLX to begin studies showing that CiaB can slow the accumulation of Ascites Fluid.
9-2-14 - NVLX submits application for ODD to EMA.
10-13-14 - NVLX submits application for ODD to FDA.
10-16-14 - NVLX secures world-wide license for Insulin producing cells for Diabetes.
11-24-16 -NVLX forms Diabetes Consortium with Professor Ann Simpson
12-4-14 - NVLX announces opening of Austrianova's cGMP Live Cell Encapsulation Facility.
12-18-14 - First live cell encapsulation at new facility just 14 days after it opens.
12-22-14 - FDA grants ODD to NVLX for Pancreatic Cancer with marketing exclusivity.
This is the end of 2014 and KW has done a ton including setting the base for everything PMCB is doing today. At this time clinical trials have not been scheduled yet.
1-7-15 - NVLX changes name to PharmaCyte Biotech.
2-15-15 - PMCB initiates first preclinical study of encapsulation of cells for Diabetes.
3-18-15 - PMCB finds in addition to everything else CiaB can do it can also consistently shrink tumors.
3-27-15 - PMCB begins talking clinical trial dates.
4-10-15 - Research shows that PMCB's Melligen Cell Line can reverse Diabetes.
4-20-15 - PMCB completes formation of International Diabetes Consortium to cure Diabetes.
5-6-15 - Melligen Cells prove safe in first preclinical test in Vienna.
7-16-15 - PMCB appoints Dr. Manuel Hidalgo to Scientific Advisory Board off of his work with CiaB in the preclinical studies at TD2.
8-15-15 - Interim Audit of cGMP facility is successful.
9-9-15 - PMCB brings Imagining Endpoints on-board to assist in Radiological Imaging for Phase IIB trials
Understand clinical trials could not have started until this last step was completed. As of September, 2014, PMCB was still waiting for cGMP approval for Austrianova's facility
10-21-15 - PMCB and TD2 begin to redesign trial design.
11-17-15 - PMCB obtains ODD from EMA and additional marketing exclusivity.
The year ends without a scheduled clinical trial with at this point a number of things not completed yet.
1-4-16 - KW outlines the rest of 2016 and has been checking off that self imposed list through-out the year. This includes trial set up for late 2016.
1-25-16 - PMCB and TD2 meet to re-design of the trial design.
2-14-16 - PMCB announces that trial still on target for late 2016.
3-31-16 - PMCB and TD2 finalize trial design and is completely re-written.
4-25-16 - cGMP finally granted by Thai Government with full go-ahead. Obviously PMCB has no control over how long it takes a country's government to approve a facility like this. Clinical Trials were never starting until this was done.
Keep in mind that this approval was only granted about 4 months ago and trials are still set for late 2016.
7-14-16 - PMCB receives patent protection of melligen cells to treat Diabetes. Diabetes will begin to play a bigger role once the Phase IIB trial is underway for Pancreatic Cancer.
At this point today we await the announcement of the Principal Investigator, IND application meeting and then a date for the start of clinical trials. It's easy to blame the CEO for the pps or the needed dilution to get to this point but unfortunately when you have just one product still in clinical trials, dilution is a necessary evil. No way around it. Until CiaB proves itself in humans, it will be difficult to sell another company on it's effectiveness. So, it is do whatever it takes to get to clinical trials. And that is exactly what they are doing. Getting CiaB into clinical trials. Once those results are in, the sky is the limit for PMCB and it's shareholders. The pps is low and well-below almost everyone's cost basis. However, you never lose money until you decide to sell your shares. Be smart. Believe in the Doctors and trust that PMCB is actually in the right hands. There will be value in the pps when PMCB is in trials and then the real value will come when there are buyout rumors and then going into trials for Diabetes. Hold those shares until trials start and begin seeing a gain from your investment.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=124700885
Great and informative article from TD2...
http://www.td2inc.com/news/what-is-an-investigational-drug
Nice article...
From the last PR, I think you are right.
Thanks for the update...
Absolutely. And I like the results I am seeing so far. Not everyone shares the same vision. I see my shareholder value gaining exponentially in the future. I understand the importance of patience and I am in no rush.
GLTA
What a true statement. And patience won't come without understanding. Always appreciate KW's updates. PMCB is a trailblazer. I wish them the best success in the upcoming 'run' so we can get this show on the road!
I think what you are saying makes a lot of sense and is a real possibility...
The fact that they invested anything in an R&D biotech with no revenue is a leap of faith no matter how you want to spin it. They could have put those pennies elsewhere. Those guys are not fools. They know what they're doing. They are keeping an eye on the technology and Fisher has been here for years.
Well, just enough interest to tell me somebody did some homework, otherwise, PMCB would not even be on their radar...
http://finance.yahoo.com/q/mh?s=PMCB+Major+Holders
I understand what you are saying Tajim. I believe in this technology and the commitment of all those involved. The price is so volatile in this waiting mode but I am not even considering selling my shares. There is way too much potential upside for CiaB.
Well, maybe all investors don't feel the same way. I certainly don't. If I did, I'd do exactly what you did. Personally, I think KW has done a great job. And I am saying that because I believe it. Not everything in this process is in his control. In my opinion, he is doing what he can and the facts show he has accomplished a great deal. No realized gains as of yet for sure but I think some may have had unrealistic expectations for an R&D OTC biotech. We are close to getting into trials. I will certainly give him the opportunity to take us across that bridge. I understand what is the hold up. I am awaiting the good news that will move us forward.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=124700885
I agree rudy... The consortium will have us ready to go... And we are already on their radar.
Nice post...
Very nice Bio....
Thank you, Bio. It's just holding time now. Also, there may be good news on the horizon based on today's crazy volume.