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Alias Born | 01/22/2014 |
Thursday, September 11, 2014 10:51:24 AM
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 I 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
** All dates listed above refer to the date of the linked PR **
For further Regen BioPharma timelines, please see my post on dCellVax progress:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=104902493
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