I am talking about the resubmission of the supplem
Post# of 5066
Posted On: 09/28/2013 11:21:00 AM
Re: patientgal #3430
I am talking about the resubmission of the supplemental animal data that the FDA is asking for. How and when will BMSN start, complete and resubmit? That's a rhetorical question btw, because I know you don't know the answer to it. Only Koos knows.
We don't know the exact reasons why the FDA asked for more data and frankly, the request makes me think someone at BMSN doesn't know what the hell they are doing.
Something you might know or find is how many INDs are kicked back asking for more animal studies?
Maybe this is common but this isn't a drug. The cells come from the host patient.
So what will more animal studies prove that the original study didn't?
Again, this is something the company, Ie KOOS, should explain to us investors.
I won't hold my breath as I have not faith in Koos.
It's too bad such great science is most likely going to be flushed down the toilet by that inept or shyster (pick which adjective you want) CEO in San Diego.
And while you stated that you signed an NDA, if Koos misled you in any way, doesn't that invalidate your NDA?
We don't know the exact reasons why the FDA asked for more data and frankly, the request makes me think someone at BMSN doesn't know what the hell they are doing.
Something you might know or find is how many INDs are kicked back asking for more animal studies?
Maybe this is common but this isn't a drug. The cells come from the host patient.
So what will more animal studies prove that the original study didn't?
Again, this is something the company, Ie KOOS, should explain to us investors.
I won't hold my breath as I have not faith in Koos.
It's too bad such great science is most likely going to be flushed down the toilet by that inept or shyster (pick which adjective you want) CEO in San Diego.
And while you stated that you signed an NDA, if Koos misled you in any way, doesn't that invalidate your NDA?
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