'I suppose the 1700 pages document is for FDA. The notified body...

'I suppose the 1700 pages document is for FDA. The notified body has already gone through the bulk of the documentation and are now only fielding questions. In the announcement it said, "The Notified Body plans to schedule a face to face meeting with the Company as a means of addressing the material and any questions, as soon as practicable... The time that the Notified Body may take to complete its final review and provide a recommendation is expected to be in the near therm."'

Well it is for each to read the above and make their own call. They have been very careful to not put an expected date on the CE, with the use 'near term'. I relation to the universe I will die in the 'near term'

Of course the Notified Body plans to schedule a face to face meeting to discuss issues, as soon as practice. The Notified Body (BSI in this case) will have as many face to face meeting with a client anywhere in the world, as long as the client keeps paying the fees. BSI will meet every week with you if you throw enough $ at them. One should not read too much into these glossy words that are designed to give SH some comfort. They are what they are. marketing fluffy words.

And so we now know officially that there were indeed 3 separate issues the Notified Body raised in written communications. Now I understand why OSL did not attempt legal action against the blogger who stated this, way before Xmas. And yest after all this time, we now have the confirmation fro the Company. Now where are all those abusive posters that maintained that OSL would have told SH if there were significant issues with the application?

So no, it is not a case of now the Notified Body is raising questions They have been doing so from the get go, and now there are more, thus the face to face meeting to try and work out a plan for moving forward. It could be another few week, or many months. We simply do not know.

And as for the FDA IDE application. It was so poor that OSL has had to file 1700 additional pages of information. I do trust they have tabulated and split the documents as FDA will send various parts to different reviewers, otherwise it will be coming back post haste. Maybe they have received a "refusal-to-file" notice, thus the huge paperwork addition. Seriously if that much has to be filed then the FDA probably rejected it. The FDA being nice collegiality folks don't actually reject it, they just 'refuse to file' allowing the client to keep spending more $ and time in reapplications.

The delays are serious, the lack of information is rather more serious.

BUT, the fact that SH have been mislead, again, must be a cause for concern. Anyone who had any experience with BSI of the FDA would have seen these issues coming and presented the appropriate paperwork correctly in the first place. Maybe this is the root cause of the turnover in their regulatory folks. Are people being pushed out due to incompetence, or are they being pressured into a half job, and then leave for a better company?

Speaking of which is the latest lass, ex SRX, still with OSL, or has she 'moved on' as well. Would not surprise me if she was the 'fall guy' for the FDA debacle.

IMO, there is a serious management problem with OSL.

One day some of the super ramps will wake up, you have been sold a pup gentlemen. I think you will be waiting an awful long time to see 50c.


The very first thing they need to do now, is get in a regulatory director who has experience with radioactive medical devices, has obtained CE marks and fronted Panel at the FDA. There are a handful around.