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

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Gwikley
Posts: 35
Joined: Thu Aug 30, 2018 9:05 pm

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

Post by Gwikley » Thu Apr 25, 2019 3:07 am

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.

biopearl123
Posts: 210
Joined: Fri Jul 20, 2018 5:13 pm

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

Post by biopearl123 » Thu Apr 25, 2019 2:46 pm

Gwikley, transfer of the IND is the key and apparently can occur before final data transfer bp

muskateer
Posts: 6
Joined: Thu Aug 23, 2018 8:33 pm

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

Post by muskateer » Fri Apr 26, 2019 7:48 pm

What is the ND? Thanks


MergingCultures
Posts: 1
Joined: Mon Aug 27, 2018 8:12 am

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

Post by MergingCultures » Fri Apr 26, 2019 10:44 pm

https://www.fda.gov/drugs/developmentap ... efault.htm

Investigational New Drug (IND) Application

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