Ann: Update on meeting with US FDA, page-23

Hey guys sorry for the delay, I've been in meetings all day and just now managed to look through todays emails.

Official response is:

Further to your query I’m pleased to return now as follows.

Over recent months we have submitted thousands of pages of pre-clinical data to the US FDA’s Division of Anti-Infective Products, covering key regulatory topics of chemistry, manufacturing, toxicology, pharmacology. Recognising, that RECCE 327 is a whole new class of broad spectrum antibiotic, we sought to clarify what regulatory pathway the FDA see’s best for our promising compound – as it may not necessarily follow that of a bacterial/fungal based (all others previously) compound’s pathway.

The FDA, having reviewed our data, offered a face-to-face meeting which took place on the 11^th of May, with many of their top brass (quite a show!). Following this, the FDA formally provided the Company clear guidance (what they would like to see) in a proposed Phase I trial of RECCE 327, if we are able to return to them an enhanced chemical analysis of the RECCE® 327 compound - with the view to clarity and understanding of its molecular structure, correlated with the efficacy repeatedly demonstrated to date and submit additional data with our application to start human clinical trials.

Simply – we are not yet cleared for human trials. The FDA has gone to considerable effort to tell us what they would like to see in a phase I trial, but have asked for more data around the topics mentioned in what I view as seeking to complete the ‘circle of understanding’ of what is promising but complex, polymeric compound.
I hope this answers your questions and welcome discussing further any time.

Kind Regards,
James

Hate to say it Tiredandhangry but you are correct. The positive out of this for me is the technology of RECCE 327 is nothing the FDA has ever seen before so it seems they cannot use similar drug testing protocols as a template for the testing of RECCE 327.
Not the end of the world and I guess long term it will not matter at all, also this will provide me with more time to load up assuming the price stays down for a little while longer

Regards
Baldy