Morning All
Tend to disagree with you on this Dave as per announcement and my conversations with BL at the GC showcase ... he was very excited the we are the only company so far that had their pre submission meeting before they went to trial ..... he reiterated how "special" this was .... personally, I think this would have been on advice from Experien
ResApp Completes Successful Pre-Submission Meeting with the US FDA
Perth, Western Australia, 14 March 2016 -- ResApp Health Limited (ASX: RAP), announced today a positive outcome from its recent Pre-Submission Meeting with the United States Food and Drug Administration (FDA) regarding ResApp’s diagnostic mobile software application, ResAppDx. During the meeting ResApp received targeted feedback from the FDA regarding the proposed US regulatory pathway, clinical study protocols, planned non-clinical evaluations and data requirements.
Good luck today ladies and gentlemen!
Cheers
GC
Ann: Trading Halt, page-190
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #