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Re: None

Sunday, 08/13/2017 9:32:32 AM

Sunday, August 13, 2017 9:32:32 AM

Post# of 10348
Seems the 510-k process is going on - we have to wait till possibly end of Sept to hear about final decision (as per 510k decision database some decisions have come in 35-45 days if everything was clean and tit was class I device. Not sure how Ac5 will be classified.

What else company can do in the meantime to increase the value of co for BO

1. File CE mark application - not sure where this stands and when it will happen - in 2017?
Even if they file the approval cycle is 6-9 months

2. Start a new trial in US for internal application - this is a biggie and will add huge value - the actual trial time will be same - less than 1 hour per patient and then 1 month follow up

Based on Europe trial - they can easily do it - but do they have resources for this?

As this will be short trial - starting it will push high - but company has not indicated as 2017 milestone.

3. Announce partnership so they can start multiple trials - unlikely as they are focused on BO

Hopefully they can surprise us by doing one of the 3 or somethig else such as submitting IND for new indication.