Page 1 of 1

? Can Geron proceed to a P3 w/o JnJ data

Posted: Thu Apr 25, 2019 3:07 am
by Gwikley
Was said that it would take a full year to return all data. Dated from the 9/28 CD, that puts full return in the Fall. Would/could Geron open a P3 without that data secured and analyzed?
Seems the $$ burn rate, if extended until sometime in the Fall, would necessitate the share offering sooner rather than later. Info and corrections welcomed.

Re: ? Can Geron proceed to a P3 w/o JnJ data

Posted: Thu Apr 25, 2019 2:46 pm
by biopearl123
Gwikley, transfer of the IND is the key and apparently can occur before final data transfer bp

Re: ? Can Geron proceed to a P3 w/o JnJ data

Posted: Fri Apr 26, 2019 7:48 pm
by muskateer
What is the ND? Thanks

Re: ? Can Geron proceed to a P3 w/o JnJ data

Posted: Fri Apr 26, 2019 9:02 pm
by cheng_ho

Re: ? Can Geron proceed to a P3 w/o JnJ data

Posted: Fri Apr 26, 2019 10:44 pm
by MergingCultures
https://www.fda.gov/drugs/developmentap ... efault.htm

Investigational New Drug (IND) Application