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Yeah efood, I dont understand why they would give a hoot.
I did to at first, then I figured it out.
That is a bold statement, you may be a very unhappy person when IND is filed soon.
cGMP is who recommended the second run, even though it is not required
PharmaCyte Biotech Engages cGMP Validation to Assist in Preparation of IND for Pancreatic Cancer Trial
cGMP Validation was established in 1997 as a full service validation/compliance firm offering services for the pharmaceutical, bulk pharmaceutical, animal health, biotechnology, biologics, medical device and medical diagnostic industries.
cGMP Validation specializes in the preparation and execution of validation IQ/OQ/PQ protocols, compliance documentation for equipment, utilities, processes, laboratory instruments, and computer systems.
cGMP Validation has new and repeat clients across the United States, Puerto Rico and Canada. International experience includes projects in Egypt, Germany, Holland, Italy, Korea, Sweden, Indonesia, Vietnam, Singapore and Tunisia.
Corporate Office located in Kansas with Satellite offices in North Carolina, Pennsylvania, Maryland, California and New Jersey.
Amusing how "Fake News" is seen as reality in these times, only time will tell.
They didn’t say that shifty shift lol
On october 16th "PharmaCyte stated this week that the second of two staggered and back-to-back manufacturing runs is already underway, and that the cells from the company’s Master Cell Bank (MCB) are growing well in this second run and will be encapsulated within the next week or two." They are letting us know the cells are encapsulated, that is why they sent out this PR.
I think they will be fine the process has been done many times before in Singapore, they are doing the same thing. "we’re confident that this manufacturing run is progressing as well as our first successful manufacturing run"
The good old days Fox, fingers crossed, something has to give.
Nice and steady climb
Nice steady volume, the anticipation is building
Yes testing of the first run should be next good news
Looking good, fingers crossed,and all keeps going well.
Pmcb, you can bet the farm
I agree efood there just letting us know we are still on track, good news
Same here tulla, I am lucky, no side affects, I only have to take 1 metformine per day, I lost some weight, and that helped allot, could stand to loose a bit more.
Nice post esusun
Yes thanks Jimmy, making him earn his pay lol
LOL so now your telling me Lohr just did a Frankenstein experiment on humans with no permission from the FDA lol that's foolish
how do you know? they had a pre IND with the FDA, and cgmp is submitting as a 2b, so it just doesn't make sense that the 2b is some kind of a decievious,trick by KW, conspiracy theory
Why would Cgmp submit it as a 2b if they didn't think it was possible, that doesn't even make sense?
cGMP Validation is playing a pivotal role for PharmaCyte and will continue to do so as it moves forward with the preparation of its IND. The role of cGMP Validation and its President and Chief Executive Officer, Jesse Gillikin, in particular, is to ensure that each and every step of the manufacturing process of PharmaCyte’s encapsulated cells completely complies with the FDA’s cGMP regulations and all other FDA requirements requested by the U.S. drug regulatory agency. In addition to ensuring that PharmaCyte’s clinical trial product meets regulatory compliance throughout the production process, cGMP Validation will also serve as a resource to Austrianova in its manufacturing process related to cGMP requirements with which it must adhere. For example, cGMP Validation will examine cGMP required documents prepared by Austrianova that concern all “production runs” of the manufacturing process and work with Austrianova to ensure compliance in every respect.
cGMP Validation will also serve, on behalf of PharmaCyte, as the agent for the “release” of the final product that will be implanted into patients before the chemotherapy prodrug ifosfamide is given during the planned clinical trial in LAPC.
I guess you just have to ask
The 1/2 study was done to requirements at that time, excellent results, safely used in humans, that's it, its done, on to phase 2b IMO
They had a pre IND so you would think they talked about that?
Actually received response 10/1 but decided to share now, I asked ir the question of how they decided to submit as a 2b, mostly because I wanted to here it from the company, and not a poster from this board.
Why are we submitting as a 2b from IR
From IR to me
Our plan is to submit an IND application to the FDA for a Phase 2b clinical trial in locally advanced, inoperable pancreatic cancer. We have retained stellar FDA regulatory experts to prepare the IND application. It will be completely up to the FDA on how it responds to our IND submission.
From IR to me
We think that way for 2 main reasons. First the aims of a Phase 1 trial are mainly (a) to establish whether a drug or treatment is “safe” to use in humans, i.e. does the drug or treatment cause any serious life-threatening side effects and (b) second, to get some idea of the effective dose range of the drug or treatment. Sometimes, different tumor types are tried to determine which is most affected by the drug or treatment. A Phase 2 trial can consist of treating 20 or so patients or even less. A Phase 2a trial is often used to better define the results of the Phase 1 trial against a particular type of cancer selected from the Phase 1 trial results.
But we have already done a Phase 1/2 trial almost 20 years ago with 300 Cell-in-a-Box capsules plus the drug ifosfamide given at a dose of 1g/m2 twice, with about 24 days between doses. As you probably know, the patients being treated were elderly, most had stage 4 pancreatic cancer (no one had lower than stage 3 disease), and all were quite sick. Not only was the treatment effective against advanced pancreatic cancer buy, according to the investigators who conducted the trial, no serious treatment-related side effects were seen. In the second early trial, the only difference from the first trial was that the dose ifosfamide was doubled to 2 g/m2. However little if any increase in antitumor effect was seen here, but significant treatment-related side effects were observed.
With the above in mind, we are referring to our upcoming trial as a Phase 2b trial because (a) we will be using the low dose of ifosfamide (1g/m2), (b) our upcoming study will be an “exploratory” study and not a “marketing approval” study (which would make it a Phase 3 trial), because we will be doing a very extensive determination of all safety parameters that today have more rigorous requirements than when the first 2 much smaller trials were done. But in our Phase 2b trial we will also be comparing our treatment to the effectiveness of 2 often used treatments for locally advanced, inoperable, pancreatic cancer (LAPC).
As an aside, although it has nothing to do with the numbering of the trial, what do you think of our chances of success are when (a) we are going to be treating healthier patients than those treated in our first 2 trials and (b) we are comparing our treatment to 2 commonly-used comparators, neither of which is very successful in treating LAPC.
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Maybe your wait is over, give it this last chance, I have been here way longer than 6 years, this feels different than any other time in the past.
Just saying, in the past he was a little grumpy, I believe deep down he wants us shareholders to be rewarded, and that time could be getting close.
Very clear to me, once testing is done thats it, then IND
Should have loaded the boat today
Uncle Kenny seems pretty happy, and content recently, I believe we are on the right track now. KABOOM
Bear CT is more mow likely bona fide now not mythical tour going to have to change your description of the ind
Last or stated a second run would be more favorable to the fda and more probable of being accepted therefore not mythical ct
Awesome
I agree esusun, cell in a box delivery system, and the ability to manufacture, freeze and ship the product, I believe that alone to be the main value for PMCB, forget all the other possibilities, that is why I continue to hold.
I agree efood, but I dont think it will hurt to sign the petition. especially if things stay the same, with no communication like the past, it seems maybe things are changing for the better now, but I dont trust that, till I see it. if things change then KW is my hero.
If pmcb is worth the same as Semma, that would make PMCB SP more than .50 per share I believe we are worth more than Semma if IND gets submitted.
Vertex to Acquire Semma Therapeutics $950-Million Deal
Sep 3, 2019 - BioPharm article dtd Sep 4th
Semma has made two major scientific advances, according to the company: the ability to produce large quantities of functional human pancreatic beta cells that restore insulin secretion and ameliorate hypoglycemia in animal models and a novel device that encapsulates and protects these cells from the immune system, enabling durable implantation without the need for ongoing immunosuppressive therapy.
cGMP Validation is playing a pivotal role for PharmaCyte and will continue to do so as it moves forward with the preparation of its IND. The role of cGMP Validation and its President and Chief Executive Officer, Jesse Gillikin, in particular, is to ensure that each and every step of the manufacturing process of PharmaCyte’s encapsulated cells completely complies with the FDA’s cGMP regulations and all other FDA requirements requested by the U.S. drug regulatory agency. In addition to ensuring that PharmaCyte’s clinical trial product meets regulatory compliance throughout the production process, cGMP Validation will also serve as a resource to Austrianova in its manufacturing process related to cGMP requirements with which it must adhere. For example, cGMP Validation will examine cGMP required documents prepared by Austrianova that concern all “production runs” of the manufacturing process and work with Austrianova to ensure compliance in every respect.
cGMP Validation will also serve, on behalf of PharmaCyte, as the agent for the “release” of the final product that will be implanted into patients before the chemotherapy prodrug ifosfamide is given during the planned clinical trial in LAPC.
At least things are getting more exciting around here, I hope the past is finally behind us.