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Actually, that has been disproved already a couple of times in the last month or so. And by some that are not fans of BMSN.
The influence of this board is rather significant. As sad as that might be at times.
Everyone remember that the regulations governing stem cell treatments and CT's are still evolving. And remember, too, only a handful of companies, with mega experience, submit an IND and experience no Q&A with the FDA thereby allowing them to go by the "no news is good news" approach.
The HemaXellerate application was the first for BMSN. It was the first submitted with a request to conduct trials in a very new market. Q&A is GREAT. It means the FDA didn't look at it and say "get the you-know-what out of here".
The efficacy data was generated and submitted sometime before 17 July. For all intents & purposes, they could find out anytime. And as I have stated, more than likely sooner than later.
GO BMSN!
LOL! I keep forgetting to turn my alerts off. I told everyone I am OCD. LOL
I am still waiting on that message from you!!!!
Thank you. I will see if I can find it.
BMSN
I am taking the calendar year rule based on what I read in various places, including Wiki. I am not sure as many of us are not sure. But, I do plan to ask Dr. Koos when I meet with him so that I and everyone else will know for certain. Unless of course he issues another PR or clarifies such on the Regen website beforehand.
BMSN
It is absolutely on my list.
Actually, nearly 70% of all US publicly traded companies operate on a calender year basis.
BMSN is among them I am pretty sure.
Go BMSN
Tee, hee.
How many times does it have to be stated that when the FDA finally decide to get off their regulating A$$e$ and render a decision, we will know.
The updates have been provided on HemaXellerate. There has been plenty of information given to explain where they most likely are at this stage.
WHAT IS THE DEAL?
How can anyone read this PR and quibble? I truly do not understand.
BMSN
It sure does look to me like Dr. Koos is keeping all his promises!
Shhhh...what is that I hear, off in the distance??? Would that be.........BP GIANTS coming this way???? Shhhh... I do believe it is!
De-listed now from shorter's paradise and now this PR! Coincidence? I THINK NOT!!!!!!!!!
BMSN!
Go ahead Dr. Koos with your bad self!
Funny, that has pretty much been the case all along, since they are a start-up and still developing. And woo-hoo, developing they are.
To the tune of securing cancer gene silencing patents & IND application for a treatment that will combat many diseases.
A/S increase---to cover the cost of having a successful, non toxic treatment for cancer. PRICELESS!
BMSN
Admit it, you're here because you bought, too!
BMSN!
You are very welcome.
Oh, so great minds think alike!
Actually, it was me!
BMSN
Well, again, there are subpenny stocks that traded on the Berlin exchange today. Dr. Koos was told, that in case he didn't know, BMSN is traded on the Berlin Exchange, 6 weeks ago.
Two facts.
BMSN
That's what I thought--the COMPANY ordered it.
BMSN
And correct me if I am wrong, but since there are still US subpenny stocks trading on the Berlin Exchange, is it not safe to say that the proposed EU changes have not been implemented and the de-listing of BMSN is a result of the COMPANY'S request?
BMSN
Absolutely! And since it has yet to be confirmed whether or not Dr. Koos was aware that BMSN was listed on the exchange to begin with (until he was informed of such of course) and subsequently request its de-listing, it is highly likely that Dr. Koos is, as he has been, doing all he can to ensure the legitimate and sound practices of this company.
My question is, now that they are delisted, how long do they have to cover?
BMSN
Well, for starters, if the company was listed unbeknownst to the company and have since been informed and an investigation into the illegal listing on the German board is underway...... well....
BMSN
ACTUALLY, that could be a very good thing! Don't try it.
BMSN
For those of you that haven't quite figured out yet that the HemXellerate line is NOT a drug but is a NON TOXIC TREATMENT, PLEASE SEE STICKY 877766 by PG.
Thank you.
The below is extracted from a 2011 NIH publication written by Bobby George. Since the publication, a lot has happened with respect to implementing what is needed in order to allow a more harmonious process for those applying for IND approval. As stated, though, this is still considered very new. However, stem cell treatment is a very fast moving market and those who had little or no interest in as little as five years ago, certainly do now.
It should be noted, too, that from all that I have gathered, Regen has complied with all of the requirements and has proved that all measures required to carry out the trials from point A to point B are respected and covered.
And though a lot has changed in terms of regulatory approaches and considerations (and will continue to change no less since this is evolving at such a fast pace) the below listed data on the origin of the cells pretty much are the same.
As I have stated a number of times, we do not know when the FDA will return their decision. It can be anytime. It will be sooner than later I am pretty sure though. Contrary to what some might insist.
-------Stem cells have a unique ability to differentiate into the specific cells required for repairing damaged or defective tissues or cells. Stem cell based therapies, encompassing collection, purification, manipulation, characterization delivery of cells for therapeutic purposes, have existed since the first successful bone marrow transplantation in 1968.
Presently, human embryonic stem cells (hESCs) are used in 13% of cell therapy procedures, while fetal stem cells are used in 2%, umbilical cord stem cells in 10%, and adult stem cells in majority (75%) of treatments.
There is still a significant gap between promising laboratory-based research and approved SCBPs (stem cell based products) in this fast emerging field. Legislation in this field must seek to both regulate and enable scientific progress without being confusing, difficult to interpret or unnecessarily onerous. In addition, the public must have confidence that its interests are protected. Few of the measures which could help to speed up the translation of SCBP from bench to bedside while still ensuring patient safety include the following.
In the U.S., classification of stem cell based therapies is based on indication to be treated. Restrictions are limited to research with federal funds. No limitations exist for research with hESCs, provided the funds come from private investors or specific states.
The FDA has developed a regulatory framework that controls both cell- and tissue-based products, based on three general areas:
Prevention of use of contaminated tissues or cells (e.g. AIDS or hepatitis);
Prevention of inadequate handling or processing that may damage or contaminate those tissues or cells;
Clinical safety of all tissues or cells that may be processed, used for functions other than normal functions, combined with components other than tissues, or used for metabolic purposes.
Manipulated autologous cells for structural use meet the definition of somatic cell therapy products and require an “investigational new drug” (IND) exemption or the FDA license approval. In 2007, the “Guidance for Industry: Regulation of HCT/Ps – Small Entity Compliance Guide” and in 2009, the “Guidance for Industry on Current Good Tissue Practice (cGTP) and Additional Requirements for Manufacturers of HCT/Ps” had been released. Clinical studies employing mescenchymal stem cells (MSCs) underlie the IND mechanism. Accordingly, the investigators have to make an IND application, which necessitates detailed study protocols describing the clinical plan as well as the preparation and testing of the therapeutic cell product.
--Compliance with the existing regulations and guidelines to ensure that the product is safe, pure, and potent meeting GTP, GMP and GCP requirements.
--Nonclinical evidence on the proof-of-principle and safety in a relevant animal model should be tried before administration to humans.
--Encourage companies to develop and validate new non-invasive methods for biodistribution studies in humans to follow the cells during the CTs. Possible markers/tracers should be evaluated and justified.
--A risk-based approach to be applied while giving regulatory approvals. Conditional marketing authorization could be a possible approach without compromising on patient safety.
BMSN!
A little bit of Immune Therapy and the good doc's Dr. Wei-ping Min & Dr. Thomas Ichim reading for you.
(What we are soon to witness has been in the making a while, folks):
www.tolerotech.com/research/paper_print/MAI_2005_RNAi.pdf
BMSN!
Incredible recent achievements in cellular and molecular biology have opened practically unlimited opportunities for the therapeutic applications of stem cells. There is little doubt that substantial financial investments and further scientific resources into the area of stem cell development will assure their practical usage in the near future.
The growing list of diseases that can be successfully cured by stem cells is expanding every day. Today, a number of malignant blood diseases have become theoretically curable due to the transplant of stem cells. Examples of such diseases are some forms of child Leucosis. It is difficult to imagine modern hematology without transplants of (hemopoetic) stem cells. The list of diseases today where such a technique is applicable exceeds 100.
-----This list includes: Rheumatoid Arthritis, Crone Disease, Multiple Sclerosis, Liver Cirrhosis, Diabetes and some drug-resistant forms of Arthritis. Oncology, as well as Breast and Lung Cancer, are other potential areas for the application of stem cells. Orthopedic practice is another area where stem cells are widely used. One of the applications here is the regeneration of large bone defects after fractures, or the regeneration of a damaged joint cartilage.
In recent years, more than 20 clinical articles have been published about the regeneration of the heart muscle after heart attacks via direct injection of stem cells and various other applications
BMSN
Let's look over the bona fide US Government records for the patents our good Dr. Min owns in his pursuit to, ahem, CURE CANCER.
A little bit of a position in a 1.2 trillion dollar market, anyone?
Wee bit of Min here
And a wee bit here
BMSN
Koos sure has been working mighty hard, and with his own funds, to fuel this little engine that WILL.
$1,657,387.49 in stock purchases alone in three years alone. This doesn't include the out-of-pocket he has provided the company.
Looks like a committed CEO with a strong trust that this stock is one day, in the very near future, going to soar!
Reduction of debt--a show of shareholder interest at heart. Ain't that something!
An April 2009 Wall Street Transcript interview with Dr. David Koos:
www.twst.com/?action=pdf&series=health&fileid=AMP600
Go BMSN!