Replies to post #3805735 on BB's Stock Haven

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for sure

[1~Eye~Jack!!]

~ RGBP = SUMMARY OF HEMAXELLERATE PROGRESS~(UPDATED NOV~2015) ;-)

Jan 24, 2013 - Pre-clinical proof of concept and plan to file IND.
http://ih.advfn.com/p.php?pid=nmona&article=55986712

Feb 5, 2013 - Announcement that IND was filed.
http://ih.advfn.com/p.php?pid=nmona&article=56150687

Mar 18, 2013 - Regen receives IND# from FDA.
http://ih.advfn.com/p.php?pid=nmona&article=56788567

Apr 4, 2013 - FDA will send a letter outlining items which must be addressed prior to initiating clinical trials.
http://ih.advfn.com/p.php?pid=nmona&article=57035344

Jun 6, 2013 - Regen responds to FDA questions (including new data).
http://ih.advfn.com/p.php?pid=nmona&article=57897013

Jul 31, 2013 - Regen in second round of discussion with FDA on a new set of FDA comments.
http://ih.advfn.com/p.php?pid=nmona&article=58628844

Sept 26, 2013 - Agreement for pre-clinical animal trials with WP Min to address FDA comments.
http://ih.advfn.com/p.php?pid=nmona&article=59372541

Oct 31, 2013 - Cook General Biotechnology to continue producing clinical grade HemaXellerate for pre-clinial and clinical studies.
http://ih.advfn.com/p.php?pid=nmona&article=59847939

Dec 11, 2013 - Update on WP Min work regarding pre-clinical animal studies
http://ih.advfn.com/p.php?pid=nmona&article=60352616

May 12, 2014 - FDA accepted the clinical protocol and the product manufacturing information; clarification on animal safety studies was requested.
http://ih.advfn.com/p.php?pid=nmona&article=62167863

Sept 10, 2014 - Regen to submit additional safety data from a GLP-certified lab prior to initiating clinical trials.
http://www.marketwired.com/press-release/regen-biopharma-provides-update-on-hemaxellerate-ind-progress-after-conference-call-otcbb-rgbp-1945965.htm

Oct 6, 2014 - Experimental protocol submitted to FDA regarding proposed pre-clinical experiments; follow-up from previous PR.
http://www.marketwired.com/press-release/regen-biopharma-submits-experimental-protocol-fda-hemaxellerate-aplastic-anemia-trial-otcbb-rgbp-1954889.htm

Oct 14, 2014 - Dr. Amit Patel Joins Scientific Advisory Board, has experience in over 17 FDA trials; will assist Regen with HemaXellerate and dCellVax.
http://www.marketwired.com/press-release/cell-therapy-expert-dr-amit-patel-joins-regen-biopharma-inc-scientific-advisory-board-otcbb-rgbp-1957807.htm

Jan 14, 2015 - Progress update for 2015; FDA is reviewing protocols for HemaXellerate GLP safety study.
http://www.marketwired.com/press-release/regen-biopharma-inc-provides-update-on-companys-progress-areas-specialization-2015-otcbb-rgbp-1982809.htm

Mar 17, 2015 - Regen received final comments and authorization from the FDA to proceed with the GLP safety study; clinical trial anticipated to begin once GLP data is reviewed by the FDA.
http://www.marketwired.com/press-release/regen-receives-green-light-from-fda-proceed-with-glp-safety-study-support-its-hemaxellerate-otcbb-rgbp-2001028.htm

Apr 7, 2015 - Thomas Ichim will present a poster entitled "HEMAXELLERATE I™, AUTOLOGOUS ADIPOSE STROMAL VASCULAR FRACTION CELLS, FOR SEVERE APLASTIC ANEMIA" at the 13th International Symposium on Myelodysplastic Syndromes. RGBP also has two other presentations scheduled for this symposium.
http://www.marketwired.com/press-release/regen-biopharma-inc-present-multiple-presentations-13th-international-symposium-on-myelodysplastic-otcbb-rgbp-2007259.htm

Apr 13, 2015 - Selection process of potential GLP labs (for HemaXellerate safety study) narrowed down to two candidates.
http://www.marketwired.com/press-release/regen-biopharma-narrows-selection-cro-candidates-hemaxellerate-glp-safety-studies-requested-2008917.htm

Apr 22, 2015 - Regen selects Charles River Laboratories to carry out the GLP safety study for HemaXellerate. Expected to be last phase of experimentation before clinical trials can begin.
http://www.marketwired.com/press-release/regen-biopharma-inc-engages-charles-river-laboratories-initiate-fda-requested-study-otcbb-rgbp-2012279.htm

Sept 25, 2015 - Regen receives audited draft report from Charles River showing no adverse effects in 10X dose of HemaXellerate in animal safety study. Expected 10-patient clinical trial forthcoming.
http://www.prnewswire.com/news-releases/regen-biopharma-inc-announces-positive-results-from-glp-safety-study-for-hemaxellerate-529494211.html

Nov 17, 2015 - Regen submits response (including GLP preclinical toxicology data from CRL) to the FDA. Expecting FDA clearance to begin HemaXellerate clinical trial.
http://www.prnewswire.com/news-releases/regen-biopharma-inc-submits-response-to-fda-questions-on-hemaxellerate-investigational-new-drug-application-550996231.html


** All dates listed above refer to the date of the linked PR **

$ RGBP $