$BMSN On Jan 26, 2016, RegenBiopharma submitted a
Post# of 5066
Posted On: 03/01/2016 1:18:59 PM
$BMSN On Jan 26, 2016, RegenBiopharma submitted an orphan drug application to the FDA for Hemaxellerate, an aplastic anemia biotherapeutic agent designed to assist in aplastic anemic condition resultant from chemotherapy, and also to act as a standalone agent for those with the orphan condition itself.
According to the FDA(see here; pg 16: http://www.fda.gov/downloads/ForIndustry/Deve...94786.pdf), approximately 2/3 applications are approved, with an average approval time being with 90 days, with the possibility for any negative decision(s) to be readdressed.
As seen here: http://finance.yahoo.com/news/regen-biopharma...00880.html Regen submitted the application on 1/26/16. And on the (assumptive) premise that the FDA granted immediate receipt of application on the date submitted, the correlative 90 day period takes us to 4/26/16, less than 8wks from today's date of 3/1/16.
There is a lot in the works for the company and investors. Some highlights of things to look forward to post-FDA approval for Hemaxellerate are the following: Orphan drug approval for Hemaxellerate, dCellvax approval by FDA, approval for small molecule/NR2F6 product, updates on joint venture with NIH/NCATS, and funding. Of course, other scenarios could play out such as mergers, buybacks, etc., but these are the most probable and concrete updates that can potentially be seen in rather short order. This has been a measurable wait, but the outcome is starting to look very promising.
According to the FDA(see here; pg 16: http://www.fda.gov/downloads/ForIndustry/Deve...94786.pdf), approximately 2/3 applications are approved, with an average approval time being with 90 days, with the possibility for any negative decision(s) to be readdressed.
As seen here: http://finance.yahoo.com/news/regen-biopharma...00880.html Regen submitted the application on 1/26/16. And on the (assumptive) premise that the FDA granted immediate receipt of application on the date submitted, the correlative 90 day period takes us to 4/26/16, less than 8wks from today's date of 3/1/16.
There is a lot in the works for the company and investors. Some highlights of things to look forward to post-FDA approval for Hemaxellerate are the following: Orphan drug approval for Hemaxellerate, dCellvax approval by FDA, approval for small molecule/NR2F6 product, updates on joint venture with NIH/NCATS, and funding. Of course, other scenarios could play out such as mergers, buybacks, etc., but these are the most probable and concrete updates that can potentially be seen in rather short order. This has been a measurable wait, but the outcome is starting to look very promising.
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