Ann: Update on meeting with US FDA, page-16

Ok I'm with you the wording is not transparent. My take on the announcement is as follows:

This paragraph was relating to past tense, the part about submitting additional data to start in human trials was IMO what has already occurred as RCE did previously submit additional data at the request of the FDA. I know it states "planned" however if the entire paragraph is read as something that has previously occurred then the context of the wording is still correct.
The next paragraph is what I see as this point in time and references the previous paragraph/period of time:


I think the wording "studies for the data requested now underway" is referring to the in human trials data. I mean why would it take several quarters to present information on pre clinical trials they've already completed. I'm sure it's complicated but they are not talking about re running animal testing and gathering new information, the information/data has surely been submitted in a way that satisfied the FDA.

Having said all of this I must say I'm unsure, this evening I emailed RCE and asked for clarification on the status. I only ask for clarification on the status of in human trials i.e. are they underway or several quarters of presenting new data prior to commencement. I will post the response should I receive one.

Thanks all.

Baldy