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RGBP - orphan drug status; once approval, the possibilities are tremendous. Good year for 2016.
$ RGBP = News Just Out!!
Regen BioPharma Submits Application to FDA for Orphan Drug Designation for its HemaXellerate!!
1/26/16 | PR Newswire
Regen BioPharma, Inc., (OTCBB: RGBP) and (PINK: RGBP) announced today submission to the Food and Drug Administration (FDA) of an application requesting Orphan Drug status for the use of HemaXellerate for the treatment of aplastic anemia.
"Because HemaXellerate is a personalized cell therapy product aimed at addressing an unmet medical need, we are hopeful that the FDA will grant it orphan status," said David Koos, Ph.D., Chairman and CEO of Regen BioPharma.
HemaXellerate is comprised of cells extracted from the patient's own fat tissue and processed using a proprietary method so as to induce a biological response in the patient that heals damaged bone marrow and restores ability of the body to generate healthy blood cells. The FDA recently cleared Regen to perform phase I clinical trials using HemaXellerate in aplastic anemia patients.
Having an Orphan Drug designation for HemaXellerate is important as it will allow for:
-- Annual grant funding to defray the cost of clinical testing
-- Tax credits for the costs of clinical research
-- Assistance in clinical research study design
-- Seven-year period of exclusive marketing after an orphan drug is approved
-- Waiver of Prescription Drug User Fee Act (PDUFA) filing fees
"Should HemaXellerate be fortunate enough to be designated an Orphan Drug, we will take advantage of the rich resources the National Institutes of Health provides in assisting development of such drugs to get HemaXellerate to market as quickly as possible," said Harry Lander, Ph.D., MBA, President and Chief Scientific Officer of Regen BioPharma.
About Regen BioPharma, Inc.
Regen BioPharma Inc. is a publicly traded biotechnology company (OTCBB: RGBP) and (OTC PINK: RGBP). The Company seeks to identify undervalued regenerative medicine applications in the immunotherapy and stem cell space. The Company is focused on rapidly advancing these technologies through pre-clinical and Phase I/ II clinical trials. Currently the Company is centering on gene silencing therapy for treating cancer, telomeres and small molecule therapies, along with developing stem cell treatments for aplastic anemia.
Disclaimer: This news release may contain forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. The risks and uncertainties to which forward looking statements are subject include, but are not limited to, the effect of government regulation, competition and other material risks.
Contact: Regen BioPharma Inc.
David R. Koos, PhD Chairman & Chief Executive Officer +1-619-702-1404 Phone +1-619-330-2328 Fax David.koos@regenbiopharma.com
The Dorsee Company Debra Dorsee +1-858-229-6082 Debbie@thedorseecompany.com
http://www.regenbiopharma.com http://www.regenbiopharmainc.com david.koos@regenbiopharma.com
Twitter: Regen BioPharma News: https://twitter.com/KoosRegen
SOURCE Regen BioPharma Inc.
$ RGBP = News Just Out!!
Regen BioPharma Submits Application to FDA for Orphan Drug Designation for its HemaXellerate!!
1/26/16 | PR Newswire
Regen BioPharma, Inc., (OTCBB: RGBP) and (PINK: RGBP) announced today submission to the Food and Drug Administration (FDA) of an application requesting Orphan Drug status for the use of HemaXellerate for the treatment of aplastic anemia.
"Because HemaXellerate is a personalized cell therapy product aimed at addressing an unmet medical need, we are hopeful that the FDA will grant it orphan status," said David Koos, Ph.D., Chairman and CEO of Regen BioPharma.
HemaXellerate is comprised of cells extracted from the patient's own fat tissue and processed using a proprietary method so as to induce a biological response in the patient that heals damaged bone marrow and restores ability of the body to generate healthy blood cells. The FDA recently cleared Regen to perform phase I clinical trials using HemaXellerate in aplastic anemia patients.
Having an Orphan Drug designation for HemaXellerate is important as it will allow for:
-- Annual grant funding to defray the cost of clinical testing
-- Tax credits for the costs of clinical research
-- Assistance in clinical research study design
-- Seven-year period of exclusive marketing after an orphan drug is approved
-- Waiver of Prescription Drug User Fee Act (PDUFA) filing fees
"Should HemaXellerate be fortunate enough to be designated an Orphan Drug, we will take advantage of the rich resources the National Institutes of Health provides in assisting development of such drugs to get HemaXellerate to market as quickly as possible," said Harry Lander, Ph.D., MBA, President and Chief Scientific Officer of Regen BioPharma.
About Regen BioPharma, Inc.
Regen BioPharma Inc. is a publicly traded biotechnology company (OTCBB: RGBP) and (OTC PINK: RGBP). The Company seeks to identify undervalued regenerative medicine applications in the immunotherapy and stem cell space. The Company is focused on rapidly advancing these technologies through pre-clinical and Phase I/ II clinical trials. Currently the Company is centering on gene silencing therapy for treating cancer, telomeres and small molecule therapies, along with developing stem cell treatments for aplastic anemia.
Disclaimer: This news release may contain forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. The risks and uncertainties to which forward looking statements are subject include, but are not limited to, the effect of government regulation, competition and other material risks.
Contact: Regen BioPharma Inc.
David R. Koos, PhD Chairman & Chief Executive Officer +1-619-702-1404 Phone +1-619-330-2328 Fax David.koos@regenbiopharma.com
The Dorsee Company Debra Dorsee +1-858-229-6082 Debbie@thedorseecompany.com
http://www.regenbiopharma.com http://www.regenbiopharmainc.com david.koos@regenbiopharma.com
Twitter: Regen BioPharma News: https://twitter.com/KoosRegen
SOURCE Regen BioPharma Inc.
$ RGBP = News Just Out!!
Regen BioPharma Submits Application to FDA for Orphan Drug Designation for its HemaXellerate!!
1/26/16 | PR Newswire
Regen BioPharma, Inc., (OTCBB: RGBP) and (PINK: RGBP) announced today submission to the Food and Drug Administration (FDA) of an application requesting Orphan Drug status for the use of HemaXellerate for the treatment of aplastic anemia.
"Because HemaXellerate is a personalized cell therapy product aimed at addressing an unmet medical need, we are hopeful that the FDA will grant it orphan status," said David Koos, Ph.D., Chairman and CEO of Regen BioPharma.
HemaXellerate is comprised of cells extracted from the patient's own fat tissue and processed using a proprietary method so as to induce a biological response in the patient that heals damaged bone marrow and restores ability of the body to generate healthy blood cells. The FDA recently cleared Regen to perform phase I clinical trials using HemaXellerate in aplastic anemia patients.
Having an Orphan Drug designation for HemaXellerate is important as it will allow for:
-- Annual grant funding to defray the cost of clinical testing
-- Tax credits for the costs of clinical research
-- Assistance in clinical research study design
-- Seven-year period of exclusive marketing after an orphan drug is approved
-- Waiver of Prescription Drug User Fee Act (PDUFA) filing fees
"Should HemaXellerate be fortunate enough to be designated an Orphan Drug, we will take advantage of the rich resources the National Institutes of Health provides in assisting development of such drugs to get HemaXellerate to market as quickly as possible," said Harry Lander, Ph.D., MBA, President and Chief Scientific Officer of Regen BioPharma.
About Regen BioPharma, Inc.
Regen BioPharma Inc. is a publicly traded biotechnology company (OTCBB: RGBP) and (OTC PINK: RGBP). The Company seeks to identify undervalued regenerative medicine applications in the immunotherapy and stem cell space. The Company is focused on rapidly advancing these technologies through pre-clinical and Phase I/ II clinical trials. Currently the Company is centering on gene silencing therapy for treating cancer, telomeres and small molecule therapies, along with developing stem cell treatments for aplastic anemia.
Disclaimer: This news release may contain forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. The risks and uncertainties to which forward looking statements are subject include, but are not limited to, the effect of government regulation, competition and other material risks.
Contact: Regen BioPharma Inc.
David R. Koos, PhD Chairman & Chief Executive Officer +1-619-702-1404 Phone +1-619-330-2328 Fax David.koos@regenbiopharma.com
The Dorsee Company Debra Dorsee +1-858-229-6082 Debbie@thedorseecompany.com
http://www.regenbiopharma.com http://www.regenbiopharmainc.com david.koos@regenbiopharma.com
Twitter: Regen BioPharma News: https://twitter.com/KoosRegen
SOURCE Regen BioPharma Inc.
$ RGBP = News Just Out!!
Regen BioPharma Submits Application to FDA for Orphan Drug Designation for its HemaXellerate!!
1/26/16 | PR Newswire
Regen BioPharma, Inc., (OTCBB: RGBP) and (PINK: RGBP) announced today submission to the Food and Drug Administration (FDA) of an application requesting Orphan Drug status for the use of HemaXellerate for the treatment of aplastic anemia.
"Because HemaXellerate is a personalized cell therapy product aimed at addressing an unmet medical need, we are hopeful that the FDA will grant it orphan status," said David Koos, Ph.D., Chairman and CEO of Regen BioPharma.
HemaXellerate is comprised of cells extracted from the patient's own fat tissue and processed using a proprietary method so as to induce a biological response in the patient that heals damaged bone marrow and restores ability of the body to generate healthy blood cells. The FDA recently cleared Regen to perform phase I clinical trials using HemaXellerate in aplastic anemia patients.
Having an Orphan Drug designation for HemaXellerate is important as it will allow for:
-- Annual grant funding to defray the cost of clinical testing
-- Tax credits for the costs of clinical research
-- Assistance in clinical research study design
-- Seven-year period of exclusive marketing after an orphan drug is approved
-- Waiver of Prescription Drug User Fee Act (PDUFA) filing fees
"Should HemaXellerate be fortunate enough to be designated an Orphan Drug, we will take advantage of the rich resources the National Institutes of Health provides in assisting development of such drugs to get HemaXellerate to market as quickly as possible," said Harry Lander, Ph.D., MBA, President and Chief Scientific Officer of Regen BioPharma.
About Regen BioPharma, Inc.
Regen BioPharma Inc. is a publicly traded biotechnology company (OTCBB: RGBP) and (OTC PINK: RGBP). The Company seeks to identify undervalued regenerative medicine applications in the immunotherapy and stem cell space. The Company is focused on rapidly advancing these technologies through pre-clinical and Phase I/ II clinical trials. Currently the Company is centering on gene silencing therapy for treating cancer, telomeres and small molecule therapies, along with developing stem cell treatments for aplastic anemia.
Disclaimer: This news release may contain forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. The risks and uncertainties to which forward looking statements are subject include, but are not limited to, the effect of government regulation, competition and other material risks.
Contact: Regen BioPharma Inc.
David R. Koos, PhD Chairman & Chief Executive Officer +1-619-702-1404 Phone +1-619-330-2328 Fax David.koos@regenbiopharma.com
The Dorsee Company Debra Dorsee +1-858-229-6082 Debbie@thedorseecompany.com
http://www.regenbiopharma.com http://www.regenbiopharmainc.com david.koos@regenbiopharma.com
Twitter: Regen BioPharma News: https://twitter.com/KoosRegen
SOURCE Regen BioPharma Inc.
That's right. IFCR is ready for a pop. I added some today and planning on adding more tomorrow.
MJMJ - picked up a few more today. I like the buying opportunity that's at hand right now.
Agreed. Let's move the bid up.
TPAC - good looking chart with plenty of uptrend.
RGBP - excellent article indeed. That's the reason I have also invested in this company.
MJMJ - well, there you have it boys and girls. Thanks Crabby for the much needed update.
MJMJ - another short squeeze in the making; I must say I enjoy watching the shorts chasing during the squeeze. Good times.
MJMJ - agreed, slowly but surely moving in the right direction. Although with news all changes and could move quickly.
MJMJ - 7's shall fall soon.
MJMJ - heavy accumulation at 5 and 6. Ready to pop.
MJMJ - heavy accumulation at 5 and 6. Ready to pop.
Expecting to go over 8 today.
RGBP - it's actually making progress and accomplished goals as set out to do. With funding at hand now, 2016 could be a year to remember.
MJMJ - it should move quickly, heavy accumulation today.
MJMJ - I've noticed the heavy accumulation at 5 and 6's today. Getting ready for another pop here.
RGBP- nice green day today. Did you get your order filled?
MJMJ - We have a runner.
RGBP - very nice Schuller. Although my contribution is not nearly as much as yours, I have also been adding.
Agreed. Adding tomorrow.
RGBP - heavy loading going on. I shall join the party tomorrow.
MJMJ - bottom is in. Loading Zone.
RGBP - bid support is increasing and appears seller is out.
It's a risky to be in, that's for sure. But the rewards have been fantastic for me.
Thanks for the report. The good thing about shorts is that eventually the "squeeze" becomes even sweeter. Load the boat.
RGBP - not a problem; I highly respect someone who posts on the boards and does research to back up their posts with legitimate data. Hard to find around here.
Just to give you a heads up; 1 eye does his homework.
ARCS is just getting started; lock n load for the run.
Not too bad today; up 60%. You have to be in it to win it.
It doesn't take much for arcs to move.
Another well thought-out post by you sir. I'm loading as much as I can as I know the outcome will be tremendous.
Agreed. Loading Zone for MJMJ.
RGBP - no change on the OS. It should rise soon. This has been the loading Zone.
Excellent news. Making progress yet, the OS remains the same.
Excellent letter. Very well written and has nice flow on all RGBP has going for it.
Excellent.