Replies to post #6722 on Arch Therapeutics Inc (ARTH)

[smooch]

Historically, if the FDA were to request additional information or trials it would occur during that 12 day acceptance of the application time frame; however, given that it is an external device and Arch is submitting, it would be unexpected.
With regard to the J&J talk- a brilliant Glaxo Smithkline manager told me long ago - if your product is going to be cannibalized, you want to become the cannibal.
Cheers and good luck.

[Amatuer17]

If you read the documentation on 510k - the 15 day acceptance is meeting primary criteria.

The decision on whether they need more test will come during actual review.

The 15 day acceptance is 1st big milestone

[D theG]

LOL, I believe they could request that, but I think Norchi and co were in pretty close contact with FDA and did what they had to do as far as number of patients