``NOT``Alert time! RedGoose is Correct on BMSN-Timeline!!
Actual BMSN Co. Timeline! Response to FDA questions: Q3 2013 Initiate HemaXellerate trial: Q4 2013 === IF FDA IND Gets Approval! Complete HemaXellerate trial: Q4 2014-Q2 2015 In license Min technology: Q2 2013 File IND on Min technology: Q4 2013 Initiate clinical trial on Min technology: Q4 2013 Complete clinical trial on Min technology: Q4 2014-Q2 2015 --- RedGoose
Actually it doesnt clearly say that at all. It says they will respond to FDA questions in regards to the IND hold in Q3.
The way I took this info from the day it came out was they will respond to the FDA IND hold by Q3 which means no later than Sept 30th but as early as July 1st. This means they will "RESPOND" to the FDA. Technically they could respond to the FDA on Sept 31st and still be in the time line. Nothing about the IND to be approved in Q3 or to hear anything from the FDA.
They will initiate trials in Q4 which means they are looking for the FDA to finally approve Q3 response to the IND in Q4 which would in turn allow trials to begin no later than Dec 31st but as early as Oct 1st. Again think of it as they could receive FDA approval Dec 30th and begin trials Dec 31st and still fall in the time line.
I am hoping for the best in all scenarios but you have to expect the worse as far as these time lines go and be patient. A lot of folks will bail if their own expectations are not met if they cant comprehend worse possible scenarios as far as dates are concerned.
Q1= JAN FEB MAR Q2= APR MAY JUN Q3= JUL AUG SEP Q4= OCT NOV DEC
Pian0wire
Hey Red! Yes, you are correct. Wasn't reading it right. And yes, people will need to exercise patience here.
___________ As always,, the above Post is "Just My Opinion!" ;-)