RE:PharmaGuy42 Hmm.. Strange, I was positive it was on the website... I fear now that it may not have been public information perhaps. If that is the case, I'll retract my comment until I find a source for it. However, my statement that their regulatory affairs is. whether in whole or in part, not being done in-house can conclusively be backed up in the following document:
https://www.telestatherapeutics.com/cms/phpwhCLSL.pdf
On Page 5:
The Company engaged an experienced regulatory consulting firm to help prepare the BLA. In August 2014, following a regulatory gap analysis with this consulting company, Telesta indicated a target date for BLA submission of March 31, 2015
I'll keep digging, I'm sure it was stated somewhere in one of those documents.