After reading back through the announcement from 18 May as well as the June investor presentation, I feel very confident holding through the CE mark approval. I feel pretty confident that we'll get a positive outcome based on the following thoughts (keep in mind that i'm no bio expert).
1. As we're getting a 4 day review, this may mean we're through the bulk of an expedited 45 day review, and any questions or further information has already been addressed and supplied to the authority.
2. We've achieved ISO certification, which from what i can gather is a requirement and a massive plus.
3. We've had an external regulatory group (in conjunction with our team) go over our CE mark submission and given the thumbs up.
Sounds like the team have been working on the submission for a long time and made sure they left no stone unturned.
In both of the announcements I re-read they mention sales in second half 2015. Once they get approval hopefully we get to see a business plan very soon after
Have no idea how the market will react following approval and have no sp prediction other than more than we are now.
OSL Price at posting:
16.0¢ Sentiment: Buy Disclosure: Held
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