I went through waiting for the CE mark with Tissue Therapies. What a complete disaster.
They used same notified body BSI. Regulators asked for more and more info, each time its another 252 days or something. Started the request for approval as a medicine, then as a device, the after appeals it was medicine again. Then finally knocked back with a new clinical trial required.
The MD was sacked, regulatory people and operations people and the chairman resigned. The company changed name to Factor Therapeutics(TIS to FTT) and had to do it all over again.
SP was trading in a range from 25 to 35c for a long time and then was kicked in the guts when the CE mark didnt come in, for the final time, and a clinical trial needed sent it down to 3c over next 6 months. Then everyone was sacked and the company changed its name. Total mess. Cannot see announcement history when name changes.
There is no sure thing in gaining the CE mark.
I hope OSL has very good regulatory people and certainly do NOT try and short cut the process.
I know this basically is a downramp, but it did happen to me, it was my very real experience with getting a CE mark and it has to be done right, or it can be a disaster.
Hope OSL get it right.
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