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I agree. News of a pre IND meeting with the FDA bodes well for cGMP. I think we are waiting on the facility to complete all Chamow recommendations and then we set up the meeting with the FDA.
I plan to attend...
Mirna Therapeutics to Host Conference Call and Webcast of Fourth Quarter and Full Year 2015 Financial Results on March 29, 2016
http://ih.advfn.com/p.php?pid=nmona&article=70853505&symbol=MIRN
Clinical trials haven't started. Only preclinical studies have been conducted. Why would you think preclinical studies would be found there? That would be way too labor intensive especially in light of the fact that many studies never result in a clinical trial...
I was referring to the intraday short volume, not naked short interest. I agree naked shorting is minimal here. Still a lot of short selling so I don't think we have fewer flippers than before... That was my point. I was talking about flipping not naked shorting...
http://otcshortreport.com/index.php?index=PMCB&action=view
Good for you! Congratulations...
Happy Friday, Pete! Have a good weekend all...
Saladan, today's volume-692,159, short-250,434. That's 36% short. I think that's too high to believe the flippers have left. I heard before that when they find a stock they like, they will just keep riding the waves. I hope you're right but too many signs tell me they are alive and well here...
The second link is a good chart and you can do it for specific increments of time.
The link is going to pull up GOOG which had over 46% interest today.
http://otcshortreport.com/index.php?index=PMCB&action=view
http://www.shortvolume.com
Nice post efood... Chips are stacking up in our favor. Love that KW addressed our IP and patents today. Slow grind for sure... But I really do believe we have the best team to get us all to our goals...
PharmaCyte’s Intellectual Property Protection Strategy
Which family of patents protects PharmaCyte’s pancreatic cancer therapy and what is your plan to extend those patents?
“Before I answer that question, let me say that our pancreatic cancer therapy has two iron-clad protections that will far surpass any protection that our patents could ever bring if we can obtain FDA approval. I will discuss this a little later in this piece, but keep in mind while reading these responses that our pancreatic cancer therapy is going to remain protected long after the patents expire.
“Everyone interested in PharmaCyte’s pancreatic cancer therapy should be focused on the family of patents that deal with the live-cell encapsulation of genetically altered human cells that overexpress a form of the Cytochrome p450 enzyme system (normally found in the liver), and specifically on only 2 patents in that family. Those patents are set to expire in the United States a little over a year from now on March 27, 2017. These are the only patents that pertain to PharmaCyte’s pancreatic cancer therapy. Now, while these patents are set to expire next year, we certainly aren’t sitting idly by and allowing that to happen.
“We do have a protection strategy in place, which includes filing an application with the U.S. Patent and Trademark Office for interim extensions extending the life of those patents 1 year at a time for up to 5 years, which we believe will be long enough to get us through clinical trials and the regulatory approval process. The earliest the application can be filed is 6 months before the expiration of the patents, and the application can be filed up to 15 days before the expiration date. PharmaCyte can and plans to file its patent extension application between September 27, 2016, and March 12, 2017.”
Can PharmaCyte apply for follow-on patents? If so, can you explain what these patents are?
“Yes. New patentable inventions related to a pharmaceutical product, also called ‘follow-on patents,’ generally encompass improvements to, or new uses for, the pharmaceutical not disclosed or suggested in the original patent. PharmaCyte anticipates extending its patent protection for its product candidates through improvements to its core technology, including:
1. New Formulations: New formulations of a known drug compound that are clinically superior to the previous drug formulation may be patentable. Developing new formulations that promote a patient’s successful therapy through such things as reduced dosing or ease of use, or that exhibit improved therapeutic outcomes or more favorable side-effect profiles, are patentable. Examples include sustained-release formulations, extended-release formulations and dosing regimens.
2. New Routes of Administration: Additional patent protection may be obtained for new formulations that permit new routes of administration.
3. New Uses: Patents directed to new uses and treatments may be obtained.
4. Combinations: Combining two or more drugs into one treatment also may be patentable.
New discoveries that may be eligible for patent protection as follow-on patents cannot be predicted at the current time; however, PharmaCyte anticipates improvements to its technology and product candidates to be generated as these product candidates move through clinical testing.”
Being that PharmaCyte’s cancer product candidates are biologics, does PharmaCyte qualify for regulatory data protection and the 12 years of data exclusivity that comes with it as outlined by the Biologics Price Competition and Innovation Act (BPCIA), which was enacted as part of the Affordable Care Act in 2010?
“Yes. This is one of the two iron-clad protections that I was speaking of earlier in this article. We will be seeking this protection and the 12 years of data exclusivity it provides. ‘Reference product exclusivity’ or ‘regulatory data protection’ is an IP right available for a limited duration, which protects an innovator's proprietary safety and efficacy data for its innovative product. This protection prevents any other party, during an exclusivity term of 12 years, from relying on the innovator's proprietary data in order to obtain marketing approval or authorizations for a follow-on ‘biosimilar’ or generic drug product. A biosimilar product is a follow-on version of an innovator’s biological product.
“PharmaCyte’s cancer product candidates are considered biological products because the capsules that are part of those products contain living, albeit genetically altered, human cells. Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapies, tissues and recombinant therapeutic proteins. The BPCIA created an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product.
“The BPCIA establishes a period of 12 years of data exclusivity for reference products in order to preserve incentives for future innovation. Under this framework, data exclusivity protects the data in the innovator’s regulatory application by prohibiting others, for a period of 12 years, from gaining FDA approval based in part on reliance on or reference to the innovator’s data in their biosimilar application. PharmaCyte anticipates its 12-year exclusivity will begin as soon as the FDA approves its pancreatic cancer product candidate.
“Countries in the European Union (EU) also provide for such data protection. Further, in October 2015 it was agreed as part of the Trans-Pacific Partnership trade deal between the United States, Australia, Brunei, Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam that biologic drugs will be given a minimum of 5 years data exclusivity.”
Can you explain how the Orphan Drug designation that PharmaCyte has received in both the United States and in the European Union is a major source of protection for PharmaCyte’s pancreatic cancer therapy?
“This is the second of the two protections I spoke of earlier. PharmaCyte’s pancreatic cancer product candidate was designated an orphan drug and listed in the official registry of medicinal products for rare diseases by the FDA on December 17, 2014. This orphan drug status assures market exclusivity for PharmaCyte in the United States for 7 years after market approval. Similarly, PharmaCyte has orphan drug status in the EU for its pancreatic cancer product candidate. This designation provides 10 years of market exclusivity in all of the countries in the EU and assistance from the EMA in the product development.
“So it should be understood that once we gain market approval, our pancreatic cancer therapy will have exclusive protections with both the regulatory data protection and the orphan drug designations. In addition, there are a number of know-how/trade secrets and trademark protections built in that we believe will make it exceedingly difficult for any company or entity to ever duplicate our pancreatic cancer therapy and complete clinical trials before we reach market approval. Conservative estimates have indicated that, given the complex nature of the trade secrets/know-how associated with our IP portfolio, we may be able to extend the protection of our IP portfolio by at least several years on this basis alone.”
In addition to PharmaCyte’s pancreatic cancer therapy, PharmaCyte also has a diabetes therapy that it is developing that will need protecting. Can you discuss how you’ll protect the therapy that consists of Cell-in-a-Box® and Melligen cells?
“PharmaCyte has a License Agreement with the University of Technology Sydney (UTS) in Australia that provides PharmaCyte with an exclusive worldwide right to use genetically modified human liver cells called ‘Melligen cells.’ Those cells have been modified to contain pancreatic islet cell glucokinase for use in developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. The Melligen cells are protected by a patent issued in the EU that is in the process of being validated in each of the major countries. In addition, there is a patent pending in the United States. The License Agreement also provides PharmaCyte with the non-exclusive worldwide rights to ‘know-how’ associated with the Melligen cells.
“PharmaCyte also licensed from Austrianova the exclusive, worldwide rights to use the Cell-in-a-Box® cellulose-based live-cell encapsulation technology for the development of a treatment for diabetes and the use of Austrianova’s Cell-in-a-Box® trademark for this technology. The diabetes Licensing Agreement grants PharmaCyte exclusive worldwide rights to use the Cell-in-a-Box® technology with genetically modified or non-modified non-stem cell lines, designed to produce insulin and/or other critical components for the treatment of diabetes.”
In simple terms, how would you summarize PharmaCyte’s strategy for protecting its IP portfolio?
“PharmaCyte has several diverse avenues available to it for protecting its IP portfolio. We plan to pursue all of these in order to extend our IP portfolio to the greatest extent possible.”
Yes, just waiting on those major milestones... Good to see you still here Mens et Manus...
It is a non-event. It is information for shareholders about how PMCB will protect their IP and patents. I have heard concerns about this and KW probably has as well. He is just helping shareholders, and others, understand what are the plans to protect our investment an Cell-in-a-Box technology. Great PR, imo, as it addresses real concerns for some shareholders. I was never concerned. I was confident KW had the IP and patent protection under control...
Realist, I think it's all how you define "doing well". If looking at the financials and PPS only, that answer is clear. However, those things can change on a dime so I don't get hung up on them while I know we are still in the R&D phase.
I feel we are doing well because we are taking all the right steps to get to market and we have a great team. I can be a visionary and see the possibilities very clearly. Some prefer to only see what is before them.
So, it really is a relative statement, "the company is doing well". It is dependent on what "doing well" means to you. I don't expect a consensus of opinion because, as explained above, some can see the possibilities and others only want what is in the "here and now".
I think R&D biotechs are NOT good for the latter because it only causes them to be very frustrated. But to each his own.
GLTU
Yes I am still holding. And I do think they are doing good.
They are consistently moving forward even though it has been at a much slower pace than I expected. There was also a lot still to be done, but now that cGMP seems to be around the corner with an IND approval, I am extremely excited about getting into human trials.
It's still risky for sure... R&D biotech with no revenue... But I see no reason to change my course...
:)
How about you?
I am feeling it too... Every day gets us one day closer to trials. Great post...
I don't think this apparent milestone is worthy of national coverage. However, we, shareholders, are pretty excited.
Countdown to IND, imo...
"Published on March 1, 2016 - Austrianova's Cell-in-a-Box GMP capsules and filling machine in action. The entire process takes place within an isolation system that maintains a Class A environment in which the filling takes place."
"Published on March 1, 2016 - Austrianova's Cell-in-a-Box GMP capsules and filling machine in action. The entire process takes place within an isolation system that maintains a Class A environment in which the filling takes place."
This just in from Ausrianova...
Thanks for your message LoveAndLight. I definitely have RGBP on my watchlist...
I agree with you saladan2. This is a speculative investment but as many others also appear to feel, it is well worth the risk.
Right now, you can buy about 50,000 shares for $3,000. Half that is even doable for a lot more folks.
The potential return is well worth the risk and like you also said, these buyers have most likely done their DD. It is easy to tune out those trying to "prove" this investment is too risky when you know the potential upside as well.
What some don't understand is that we know the risks but we also pay attention to all the positives as well. Those far out weigh the risks, for me anyway...
No worries. :) Yeah, I think he is right that we will have the funds and will see more value with trial milestones...
Absolutely!
I don't understand your comment. No one is being passed up or left out... They found 4 types of PC. This new knowledge will likely impact all PC treatments.
"Researchers in the U.K. have made what is described as a "breakthrough reclassification" of pancreatic cancer, which offers new opportunities to treat the often-fatal disease."
I tend to agree with him...
That is interesting. I wonder if this new knowledge had or will have any impact on our trial design...
This is a previous post from admin. May explain a couple of things for you... It is the sticky above...
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Well trying to book value an R&D biotech will always be misleading...
What is the value of curing Type 1 diabetes of making inoperable pancreatic cancer operable?
"However, book value has little application in the world of biotech investing, because it can be years before a biotech researcher's hypothesis can be proved to the extent necessary to win over global healthcare regulators, such as those at the FDA."
Book value does not apply here...
http://www.fool.com/investing/general/2015/06/27/using-a-dcf-model-to-value-biotech-stocks.aspx
Agreed...
Not really because this kid was recruited by one of the most renowned Pancreatic Ongologists around. Dr. Daniel Von Hoff contacted us to use CiaB technology and he has now participated in redesigning our P2b clinical trials for maximum success. Additionally, TD2 will be our US CRO and has access to many patients with PC. I have not forgotten these key facts....
I feel very good about the science and I like how far management has taken us to get this closer to market. Dilution is expected and the fact that these guys have gotten a lot of shares for compensation is ok with me. I hope they hold on to them and in the end we are all happy we waited patiently for CiaB to steal the show...
Thanks for sharing these messages Pete...
I stand firm and apparently understand KWs position. He is doing everything he can... Some things just take time. He mentioned a lot of the things that need to pass inspection for a facility to get cGMP approval. They seem to be aware of what is needed and are staying on top of Austrianova to get it done. I am satisfied...
I believe KW has taken the steps to add shareholder value. We are ready to start trials, have all team members in place and are just awaiting the facility to be cGMP ready.
My objectivity is right in line with my priorities. Unlike you, I am focused on the science and that is looking good. I am concerned about the length of time to get to trials but I don't blame that on the management team.
What more do you think they need to have done to add shareholder value?
That's a nice long list of professionals investing in this technology...
I have a lot of faith in Ken Waggoner and have seen first hand how far he has taken this company in terms of the advances needed to get us to trials. The fact that he is meeting twice monthly with all entities working towards cGMP compliance is evidence to me that he continues to be very involved in every aspect of the business. And he is steadfast in his commitment.
I have always appreciated his transparency and continue to trust his efforts are genuine. His father died of PC. I think, like Dr Von Hoff, he has a personal interest in seeing this technology help PC patients.
Management is key for me and what he has done for this company is pretty amazing so far...
cGMP has certainly been a long time coming and it looks like we are still working towards it. I still believe this technology is revolutionary. It might be the reason cGMP is taking so long. When we get it ready to go however, I believe CiaB will bless many lives.
I am long as always... And want to thank KW again for his steadfast commitment and ongoing efforts as well as the most recent PR shareholder update....
It sounds to me like Chamow has:
1) told Ausrianova what needs to be done
2) is having regular communication with TD2, PMCB, and Austrianova to discuss progress towards compliance issues and
3) are writing up the CDC portion of the IND application.
The CDC section is what the FDA would consider in approving the application for the facilities compliance in meeting good manufacturing processes, as far as I understand.
"After Chamow & Associates (Chamow) inspected the facility in December 2015, they prepared a detailed audit report for Austrianova to use as a blueprint to complete the work necessary to insure that the facility is cGMP compliant. Twice monthly PharmaCyte, Translational Drug Development (TD2), Chamow and Austrianova hold a lengthy teleconference to discuss the progress that is being made in completing the items necessary for the facility to become cGMP compliant and in generating the bulk of the CMC information needed for the Investigational New Drug application (IND) we plan to submit to the FDA. A detailed Gantt chart has been prepared to monitor the progress being made and to assist in keeping the project on schedule."
“Evidence of the cGMP compliance of the encapsulation facility must be presented to drug regulatory authorities as part of the Chemistry, Manufacturing and Controls (CMC) section of the IND. It must be deemed satisfactory by the FDA before the clinical trial can begin. The cGMP facility information makes up the bulk of the CMC information package, which, in turn, makes up the largest and arguably the most important part of the IND. PharmaCyte is very fortunate to have retained Chamow, an outstanding biopharmaceutical consulting firm, that specializes in the inspection of facilities for cGMP compliance and in the preparation of the CMC section of INDs. Chamow is working in concert with TD2 to prepare the CMC section of our IND for the facility in Thailand.”
No worries. Haha