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.
Here...listen to real scientists...
"Commenting on his selection, Dr. Hidalgo said, "I am pleased to have been selected to be the PI of this important clinical trial, having been a part of its overall design. I have been involved in numerous successful clinical trials and will be drawing on that experience in this one. I believe that the Cell-in-Box® plus low dose ifosfamide combination chemotherapy may well prove to be of great value for the development of new therapies for pancreas and other solid tumor cancers. This novel technology has exceedingly broad application. I am looking forward to working with other clinical oncologists in the U.S. and in Europe to insure that PharmaCyte's therapy meets the critical unmet medical need the study is designed to address."
Agree...waggs has a ton of Bod/Advisory including Judd and Hidalgo that have guided this filing with FDA...also contributing is Medpace and cGMP Validation along with others...I dont think this technology will easily be dismissed...this will go to trial...listen to the real scientists.
And when waggs tells us all is good...watch the volume explode and pps will zoom because everyone who panicked will want to get back in at higher prices...kaboom!
Agree tulla but I do think they are waiting for the official letter before letting us know...I think that is fair.
Hmmmm....so waggs may already know what this clinical hold is about...stay tuned!
"The clinical hold order may be made by telephone or other means of rapid communication or in writing. As soon as possible, and no more than 30 days after imposition of the clinical hold, a written explanation of the basis for the hold will be issued by FDA and sent to the applicant. The letter with the explanation will identify the studies under the IND application to which the hold applies, and will briefly explain the basis for the imposition of clinical hold."
Lol...aren't you speculating?.
Lol...waggs is going for a phase 2b trial and hoping for a fast track...fda wants to cover all bases before granting this...simple!
Esusun...since this is for an unmet need and many people have no choice but to die from it so I think the fda will approve this technology for a trial...it already has a successful history from those 2 previous trials in Europe. Cell in box has no adverse effects itself and the chemo drug used with it requires only 1/3 the amount for treatment and that drug is already FDA approved...pancreatic cancer patients desperately need something like this....
Jeez...all this because the fda needs more time to understand how cell in box works?...30 days was not enough time. It happens all the time with new technology!
Let's see where we stand...certain scientists said we would never get Orphan Drug Designation...but pmcb did both from FDA and EMA...then these same scientists said pmcb would never get a Pre-Ind meeting with the FDA...but pmcb did...then these same scientists said cell in box would never pass the necessary required testing required by fda...but those tests were completed successfully ....then the same scientists said pmcb would never file the IND...some scientists are batting .0000
Can't wait for IND approval...gonna be great!... kaboom!
Boo hoo to you!...pmcb has presented to FDA a ground breaking technology to treat an unmet need...fda has more questions...pmcb will answer them...then we are off to the races...will you be ready?
So there is another delay not caused by pmcb...we have been down this road before...pmcb has always perservered... it will again get past this delay...
Just blah...blah...no evidence...as usual.
Agree 100%...first 2 clinical trials I believe were in Germany...good post.
Nope...its about the potential of cell in box... cancer and diabetes is where the big money is...they could buy it and invest more into it and make tons of money.
I don't know but seems Sigma Aldrich is marketing cell in box...it must work? Merck owns Sigma Aldrich and they may be a good candidate to buyout pmcb...I am sure they are keeping close tabs on the IND filing.
https://www.sigmaaldrich.com/technical-documents/articles/biology/cell-in-a-box.html
Its cellulose and causes no immune response...it can last in body for up to 2 years and can be removed...its safe.
Another 1.3mil bought at .0111...get your cheap shares now before waggs answers those IND questions from fda...
And all sec filings are current...and cell in box has had 2 successful clinical trials for pancreatic cancer...2 more facts you can add.
Huh...lol
And could it be that an interested big pharma fed some last minute questions to FDA to get answers...you never know...I think it is a real possibilty.
Fda will figure out how Cell in a box works and will lift the hold....they need more time...that's it...like I said before...the drug is already in use so its not about the drug...cell in box has no immune response so it's not that...I think it's all about the complexity of this technology. FDA has never seen anything like this before...
How do you know this?
Fda will lift hold when their questions are answered...I believe the fda learned quite a bit about cell in box and wants to learn more....seems they are not questioning the use of the drug involved here as that drug is already FDA approved for use...and besides cell in box will require only 1/3 the normal dosage so that should be a plus in eyes of fda.
This technology is complicated...fda needs more time to review the results of earlier clinicals ...to review FDA required improvements made during the pre IND meeting including being able to reproduce identical cells...and to study the company plan going forward if fda give IND approval...etc...no worries here...just need a little more time.
Get those cheapies....
Many have tried to stop this company and their technology and have failed...next.
Fact is...
Cell in box for an unmet need is a needed treatment for pancreatic cancer as there is no other available at this time...this technology happens to be very complicated and required a lot of testing to get it to FDA doorstep ...there are also successful test results from previous clinicals that FDA had to review...they have already asked waggs questions on 5 occasions during the 30 day review period...my take on this is that FDA still have other questions for waggs to address before approving and simply ran out of time...that's why a hold was issued by fda...so when the rest of the questions are answered we can move on to clinical trial...keep in mind cell in box is not a drug... just a delivery vehicle to site of tumor. Also cell in box requires only 1/3 the normal amount of chemotherapy to treat this cancer...so I don't think FDA is worried about effect of drug as it is already approved for use by fda... I think it all comes down to FDA wanting to clearly understand how this technology works.
Esusun...this sell off was just panic by holders who are not familiar with the process...its simple... FDA ran out of time to understand how cell in box works...it is a really complicated technology...after all waggs mentioned he has already been contacted 5 times by FDA to answer some questions...no concerns here.
No worries here ferenc...pps goes up...it goes down...the time needed for FDA to better understand this technology ran out...so they asked for more time...its that simple.
Good info....thanks.
Look at it this way...if the technology was rubbish the IND would have been rejected...placing a hold does not mean rejection...it means more time is needed for FDA to keep reviewing and collecting info...I would think that our CMO and P.I. understand this technology a lot better than the fda...the fda has had only 30 days to review cell in box...
Well another chance to get cheapies...a hold does not mean "no"...fda needs more info...remember this is a very complicated technology and I am thinking the fda needs more understanding how things work before they give the go...waggs and crew will work on getting the info FDA needs and then it's a go.
Will waggs do it?
Give us an after hours pr tomorrow to announce some great things?
Lol...they pooped and someone just scooped up 523k in one shot...lol.
Someone is working very hard to push share price down...keep an eye on level 2...
And waggs did mention in a not so recent pr that trial funding opportunities where available once IND was approved so I think this could also be part of an upcoming pr....
Yep...waggs sounded confident in that last pr...might be waiting for other pieces to fall in place and then package it all in a nice pr.