Replies to post #6724 on Arch Therapeutics Inc (ARTH)

[21money21]

Ok so application should be accepted I'm sure. Just was a little worried because that is a very small trial and didn't think it would be a problem if had ce already in place and more patients that have used it. Well, no matter what things are progressing and when they start internal trials this will really get going. Once ce/510k approved j&j will buy us out. Waiting for some sort of approval I'm sure and than will buy their competitor I'm sure

[Amatuer17]

510k application steps

Submitted - 17th July

Acknowledgement received - 25th Jul (within 7 days as per guideline)

8th Aug - Acceptance review result

This is key as the 1st committee goes through full checklist and gives acceptance decision (acceptance - or not acceptance and put on hold)

Not sure company will issue PR for this step but if they are put on hold or rejected - it is a material event so company will have to issue PR

So we can see some signs by Aug 10-11 - a PR.

The process is quite quick