Oh, and to counter my previous statement with the

Oh, and to counter my previous statement with the opposite possibility...

"We are pleased with the responses that we have provided to the FDA and look forward to initiating our clinical trials," stated David Koos, Chairman and CEO of Regen BioPharma. "Although it is possible that a second round of comments may be issued, we feel this process is extremely useful to creating a clinical trial that is optimized for safety and detection of efficacy."

SAFETY.... EFFECTIVE.

If the FDA is fast tracking HemaXellerate with ODS (orphan drug status), they would want to make sure that the drug is COMPLETELY SAFE, since fast tracking an unsafe drug has MASSSSSIVE complications.

The FDA is ensuring HemaXellerate is SAFE for FAST TRACKING.
Aka, ODS, what BMSN has applied for.

That is the reason for the delays, because since this is re-constitution of biologics and cells from your own body, there is 0 rejection possibility.  Makes it pretty damn safe.  So perhaps it is specifically the CLINICAL TRIAL ITSELF and how it is to be PERFORMED.....  not the drug.... The drug is safe.  There is 0 rejection chance in this drug.  Its actually incredible the system they are using for administration.  Stem cells really are a medical miracle.

IMO, its because the trial procedure that they have outlined and all the steps herein, do not prove to the FDA's satisfaction... That the trials in which they submitted originally would PROVE BEYOND A DOUBT to be effective.

They are simply coming up with more tests and alternate procedures so they can PROVE BEYOND A DOUBT that HemaXellerate is EFFECTIVE, SAFE, will be IMPLEMENTED SAFELY, and there is NO HARM TO THE PUBLIC.


REMEMBER:  IF HEMAXELLERATE HARMS ANYONE- THIS COMPANY AND EVERYTHING WE HAVE IS OVERRRRRRRR

so be thankful for these delays- it means innocent people are not being harmed, and we get to keep our money since the FDA is covering everybodies ass.

VERY MUCH IMHO.  ALL OF THIS.

EDIT:  In conclusion;  these delays are necessary to protect people like you, me, children, our parents, etc.  Be patient, lets make sure everything is EXACTLY AS IT SHOULD BE before bullrushing forward.

oh, and yeah... I'm pretty sure most people were caught off guard and needed funds to clear before buying more into BMSN.... most logical speculation I have.....

Predicting slow rise in PPS til next PR.... Maybe hover at .006.