Right...well like a lot of things, this 'depends'.It's got a lot...

Right...well like a lot of things, this 'depends'.

It's got a lot to do with the nature and magnitude of the comments. From what I know (basically not a lot!!), there are a lot of comments and there are a sprinkling of suggestions! Par must go through them all and work out how to implement them and also what are the ramifications of doing so. Some will be basic/easy...others will need Grey Matter deep thought.

At least some of these will no doubt have to have a few KOL's cast their eyes over it and definitely the Bio Statistician will be involved, a revised SAP will most likely need to be formed too.

I don't think its months of work, it definitely is weeks.

I'm in such a better position from an anticipation point of view as the ball is in our court, we aren't waiting for the Authority on this, PAR will take the time to do it properly. It's one of the things we can't fault. They will also be wary of trying to get this done soon but also will be careful to think and implement thoroughly.

Once that is done, they will be in the position to formally submit it. The process then is relatively straight forward, the FDA have a statutory 30 days to get back to us at which point in can go one of two ways:

A) Accepted in full, revised IND is a go

B) Some Question/discussion or refinement required


In theory, if we follow their comments suggestions and guidelines, there should only be one 30 day iteration, we have been through months and months of waiting and some to'ing and fro'ing already... I don't think I'll be able to cross me fingers any more than I already have.





My views only, don't rely on any one poster, and better to DYOR.