Based on the report:
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 thetiming 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”.
Obviously, it is clearly stated in the announcement.. someone try to twist the words or even manipulate the announcement!!
I believe our MD, Mark Diamond is a genuine and down-to earth guy, he just won't simply put up those fancy words to make our shareholders happy for a second... please make your own judgement here....
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- Ann: US FDA Type C Meeting for ATL1102 in DMD
Ann: US FDA Type C Meeting for ATL1102 in DMD, page-47
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