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TELESTA THERAPEUTICS INC T.TST

"Telesta Therapeutics Inc is a biopharmaceutical company. The Company is engaged in the research, development, manufacturing and commercialization of human health products and technologies."


TSX:TST - Post by User

Post by Xiawen13on Apr 11, 2016 9:50am
181 Views
Post# 24751200

Ipsen is not trying yet to commercialize MCNA

Ipsen is not trying yet to commercialize MCNAAs I suspected since a few months already, Ipsen is waiting for FDA approval to start effort to commercialize MCNA in other jurisdiction outside USA.

In a recent press release (link below, french only), it says:" FDA informed Telesta that further phase III trials would be necessary. Ipsen will engage European reglementation body to identify what is requited to commercialize MCNA"



(page 14) https://www.ipsen.com/wp-content/uploads/2016/03/IPSEN_DDR_2015-VDEF1.pdf

La FDA a indiqu Telesta qu’une tude clinique de phase III supplmentaire tait ncessaire pour tablir l’efficacit et la scurit du MCNA. Ipsen entamera des discussions avec les agences rglementaires afin d’identifier la voie rglementaire et les potentielles exigences pour enregistrer le produit en Europe et dans les territoires cls pris en licence.
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