Replies to post #5426 on Arch Therapeutics Inc (ARTH)

[Amatuer17]

That is my concern - that was the day SP dropped

Can someone who contacts ARTH IR can ask this question?

Here is what someone posted from stockgumshoe - seems we are not allowed to copy completely here

"Norchi said the main thing holding up Arch’s plan to apply for EU marketing authorization has to do with the contract manufacturer doing quality control of the manufacturing process according to norms for drugs rather than devices.

The paperwork burden for QC for drug manufacture burns many man-hours. This same regulatory burden for devices is not only somewhat less (though quite substantial) but also formatted in a radically different way.

An EMA inspection of the plant that would have supported a device marketing application was bungled because of this paperwork for quality control as put together by the contract manufacturer.

Norchi does believe the application for use of AC5 as an agent for hemostasis in the EU will be made during calendar 2017, but at this point has no idea when or which quarter. "