good news hang on, page-15

This is all good and the further slight delay is a small price to pay for a better study protocol.

Remember this trial will be a cornerstone for the major Phase 3 Study(s) leading to marketing approval....subject to a positive outcome of course!

So all this to and fro is just part of the process with the officer in charge of this IND probably utilising the expertise of some very wise heads in the FDA to ensure validity of the outcomes.

I would expect a very quick response from the FDA and a lifting of the Clinical Hold on receipt of the response.......take it as given!

Evidence of clinical efficacy & safety in this study is critical and will be the absolute rocket behind the share price of course and that will take a bit more time. However tickets are on-sale now and the demand is fairly solid!