Posted On: 08/20/2014 5:14:15 PM
Post# of 5066
Unfortunately, the fact the article is over 2 years old without significant news might be an indication it isn't a significant development yet.
With the Regen share dividend, I really thought we were close to something legit and big.
Now over 3 months have passed since the FDA accepted HemaXellerate I protocol and manufacturing, but did not accept safety studies as being sufficient for their ok. What the questions/clarifications/issues were/are we have no idea. But each day that goes by without a follow up PR and without news of approval may no longer indicate we are closer to approval, it may mean just the opposite. The fact that in 3 months, BMSN/REGEN has not been able to clarify the safety reports to FDA's approval, just might mean no approval will be coming since they accepted and approved the other aspects within a week of submission.
Will dCellVax follow suit? Only time will tell. Right now I no longer see time on our side.
With the Regen share dividend, I really thought we were close to something legit and big.
Now over 3 months have passed since the FDA accepted HemaXellerate I protocol and manufacturing, but did not accept safety studies as being sufficient for their ok. What the questions/clarifications/issues were/are we have no idea. But each day that goes by without a follow up PR and without news of approval may no longer indicate we are closer to approval, it may mean just the opposite. The fact that in 3 months, BMSN/REGEN has not been able to clarify the safety reports to FDA's approval, just might mean no approval will be coming since they accepted and approved the other aspects within a week of submission.
Will dCellVax follow suit? Only time will tell. Right now I no longer see time on our side.
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