Posted On: 09/26/2013 12:06:51 PM
Post# of 5066
Re: patientgal #3330
As I have stated before, I have been in enough biotechs to know how the game is played.
While you were right that HemaX IND wasn't outright denied, BMSN has to go back to the drawing board and give the FDA what it wants (and what wasn't present with their first submission).
That's fine as this CRL-like request by the FDA still allows BMSN to "fine tune" the data to the FDA's satisfaction (assuming the new animal models show that HemaX works).
But, the question not addressed in the PR is how is this cashless company going to pay for it?
And if you do set up a Lemonade stand, I'll gladly purchase a glass as long as you don't put something toxic in it!
While you were right that HemaX IND wasn't outright denied, BMSN has to go back to the drawing board and give the FDA what it wants (and what wasn't present with their first submission).
That's fine as this CRL-like request by the FDA still allows BMSN to "fine tune" the data to the FDA's satisfaction (assuming the new animal models show that HemaX works).
But, the question not addressed in the PR is how is this cashless company going to pay for it?
And if you do set up a Lemonade stand, I'll gladly purchase a glass as long as you don't put something toxic in it!
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