Arch Therapeutics Inc (ARTH)

[BonelessCat]

Successful human trials and EU approval are not baby steps, but there is still a LONG way to go after that. Money will still be needed, although hopefully it can be raised at higher prices.

EU approval will lead immediately to a partnership for manufacturing, marketing and distribution.

Though on-label use will only include conditions tested in the first trial, off-label use may include any other uses deemed safe by attending physicians. More importantly, adding additional uses will be a simpler matter than even the recent short trial as further small studies are permissible for each. Though I have no idea wehat the company strategy is here, whether to seek additional topical and dermatological use, or to advance quickly to internal surgical use, endoscopy etc, these additional label approvals only require short studies resembling that recently completed.

Also, since all the hard work was done by ARTH, the likelihood of a license is diminished and a 50/50 partnership with profit sharing greatly increases that would include milestone payments along with terms for Asian market, British approvals (Canada, Australia, New Zealand) as well as US FDAs.

So, any partnership or license terms will include first, the likelihood of capturing 15% or more of the EU $1 billion market in the next 5 years as well as approval of global use across nations and regions in the same time-frame plus the 10 year projection of >15% of a global >$7 billion market.

A long winded post to say, no it's not a long way to go to a substantial revenue stream.

I tried to come up with some recent agreements to ballpark some possible upfront and milestone structures, but so far I have not located anything that remotely compares with the paradigm changing nature of AC5.