Posted On: 03/01/2016 1:18:59 PM
Post# of 5066
$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.
(1)
(0)
Do your own DD. Assume everyone here is either an amateur trader/investor or a paid interest such as a compensated pumper/basher. My posts are strictly for entertainment purposes. I am not on Wall St., do not work for a group, and only get paid when my personal investments materialize. I am only responsible for my own gains and losses; no one is to blame for my mistakes or for any advice taken from postings; likewise, I am not to blame for any advice you take of mine, regardless of gains or losses from doing so. Good luck to all; may you live long and prosper greatly.
Scroll down for more posts ▼
