Tuesday, May 22, 2018 1:06:48 PM
The FDA clinical trials web site lists the P3 a being completed as of 12/10/17.
298 was provided by the FDA.
An NDA can not be filed until 298 is reached.
Completing a P3 and filing a NDA are two events , not one.
The last patient was treated late 9/16, 20 months ago.
That date coincides with two events.
1) The start of ARB.
2) The scheduled completion of P3.
kersten said the mortality rate was too low and took it upon himself to change the P3 parameters WITHOUT asking the FDA.
That resulted in a 7 month delay.
If kersten knew the mortality rate was low, HE KNEW What THAT NUMBER WAS !
He knew it 9/16 and therefore knew it in 8/16, 7/16 *and so on*.
He waited until a few days before the enrollment was due to be completed.
He could have, should have requested FDA permission well before 9/16.
***In 20 months how many patients have expired ?***
BTW: The monthly enrollment chart has been removed from the Cel-Sci web site.
It is still part of SEC filings.
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