All clinical aspects are 100% ok......I'm expecting one big trial including EMEA and FDA - with "pivotal data" to be used in both markets.
"The meeting was constructive and provided clarification on a path towards initiating a Phase IIb/III study in the US."
Non-clinical requirements are to be further reviewed and agreed with the FDA to assess if and how they may impact on the timing of clinical study initiation. The feedback will be reviewed by our internal team and incorporated into our global clinical development and commercialisation plans.
Mark Diamond CEO of Antisense Therapeutics said: “Based on the guidance meeting with the FDA, together with prior feedback from EMA and world leading DMD experts, we are reassured that the data from our Phase II study is encouraging and that it is reasonable and appropriate to advance the program towards potentially pivotal clinical studies. It is our goal to bring this medication to as many DMD patients worldwide as possible”.
ANP Price at posting:
20.0¢ Sentiment: Buy Disclosure: Held
A personalised tool to help users track selected stocks. Delivering real-time notifications on price updates, announcements, and performance stats on each to help make informed investment decisions.
(20min delay)