News Focus
News Focus
Followers 5225
Posts 24469
Boards Moderated 5
Alias Born 09/20/2000

Re: mscolleen2003 post# 47412

Saturday, 03/09/2013 12:22:29 PM

Saturday, March 09, 2013 12:22:29 PM

Post# of 158400
mscolleen2003, with your call to the FDA…

I 100% believe you. I do believe that the BMSN stem cell drug (HemaXellerate I™) through its wholly owned subsidiary, Regen BioPharma, Inc., has been approved for IND status too. Still, 100% confirmation will do well by the market to ”officially” come from the company or the FDA. I do think that such confirmation is coming.

Also, just so you know and understand the process, I spoke to the people at the FDA Office of Orphan Products Development (OOPD) too. The lady that you spoke with concerning the Orphan drug had never heard of this drug because they won’t hear of it until "after" it is first approved for Investigational New Drug (IND) status.

I was also told by the FDA OOPD that the company will have to first get IND approval for their drug then it will be sent to their office soon after to be awarded Orphan Drug status. I was not given a time frame, but I was told that the FDA tries to get everything done very quickly with the cooperation from the company involved.

This is why they have not heard of it yet. I do believe that it is coming, but read the post below to get an understanding of some previous due diligence (DD) on the issue:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84957802

v/r
Sterling

Discover What Traders Are Watching

Explore small cap ideas before they hit the headlines.

Join Today