PNB ready to enter Phase III development with PNB01 in Major Depression
Pharmaneuroboost (PNB) reported that it received clearance from the Institutional Review Board (IRB) to initiate its first phase III study with PNB01 in the USA.
“We are particularly excited to have passed this first hurdle on our way to start phase III with PNB01 in the USA, which is a rather unique achievement for a small Flemish biotech company”, says Chief Executive Officer Erik Buntinx, MD. “PNB’s experienced management team has been preparing this phase III program for a long time, and we are proud to reach this important milestone, having met all organizational, regulatory, financial and also ethical requirements”.
“We expect to obtain similar approvals in Germany and Canada in the very near future”, says Philippe Lemmens, PhD, Clinical Study Director. “Previously, competent authorities already agreed with the clinical trial protocol design, and so we expect to start recruiting patients in the coming month, pending their final approval”.
PNB01 is the first of two front-running, late stage proprietary projects of PNB.
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