Morning All:
As many of you already know I was slated to have a conference call with the minds in-the-know of pharma & FDA going's on. We covered a number of issues as I asked many questions and received many answers albeit generic answers as they could not provide company specifics. Many of the questions I already knew the answers to, or at least felt a certain degree of confidence with based on my experience in the business and my own personal research. I do hope to be able to reiterate a number of key points sometime today when my schedule will allow. Then again, Koos may release that PR and I will at last be able to take a mental break for a wee while.
That said however, I can quickly note the following that was confirmed for me:
Regen could very well be utilizing what some see as a safety period post FDA Q&A. We all know that with typical IND submissions if nothing his heard from the FDA after thirty days, that is considered good news and the company is essentially authorized to begin trials. When Q&A are present however there resets a waiting period. If the company satisfied all of the questions with the required data and there were absolutely no doubts to them about such, then it is not unlikely they are awaiting the lapse of 30 days from proof of receipt of the information to begin. Playing it safe.
Understand since Koos indicated there was a possibility of further Q&A he was not obligated to disclose such with further Q&A. However, if they were denied WE WOULD HAVE KNOWN BY NOW. Further, there would be additional evidence of this. It would NOT have included the finalization of the Trademark application for HemaXellerate, noted as having been completed just in the past week or so.
To add to that, there is the plausibility of application for Orphan Drug status during the course of all this. There is too much to detail with this right now so I will get back to that later. But I want you to chew on that for a while.
With respect to BP funding smaller companies during trials, again, this is not uncommon. Not by any stretch of the imagination. One such case we discussed last night is that of a biotech start up in the U.K. that was created to proceed in the development of an anti-coagulant discovered by the University of Cambridge. Index Ventures started the company on a 200 million dollar fund that was closed in 2012 with capital from GSK & J&J.
There are several more I will cite but must do later.
As always, you must have confidence in the minds behind this company. If you have not familiarized yourself completely with the backgrounds of these doctors, I implore you to do so post haste. If you don't stand long & strong with BMSN on that alone, then somthin' is wrong with ya!
Gotta run. Have a great day. I will respond to PM's as I can.
GO BMSN, ENTB & MEDS.
