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tradero

08/30/13 4:43 AM

#9382 RE: binchey #9381

If that is our only concern... then not much of a problem. What do MENA countries + Switzerland really mean?

European Union: about 400 million people... where individuals have a similar economic power than US citizens

Switzerland: very small population and those interested can travel a few miles to a neighboring country to get Vitaros

MENA countries: relatively speaking very few people who can afford Vitaros...

IMHO

markkind

08/30/13 9:02 AM

#9386 RE: binchey #9381

Agreed any bad news will impact future contracts.

Also APRI has a hard time meeting goals.

So the launch date of a Rom Temp product is critical but probably quite a ways off

I think I understand why they had a secondary. Something tells me Mgmt anticapted issues.

eicoman

08/30/13 9:56 AM

#9395 RE: binchey #9381

that is not true, the MENA countries follow Canada, other countries will follow the larger EMA EU approval vs Swissmedic now that EU approval is in, I checked this out, The Swiss rejection was not on efficacy or safety so that says something positive, it's not unusual for reg. agencies to ask for more data, luckily it's only about shelf life and APRI will work with them. Switzerland is a very small country, Germany is 10 times larger.