Makukes 'Bs if you have 20 years experience I wonder how much...

Makukes
'Bs if you have 20 years experience I wonder how much Cafa have. OMG looks like all the non holders are expert in the trade..... '

A) I have posted time and again about the deficiencies in the regulatory process and approvals at OSL. To be met with derision - so be it. We are all entitled to hold different views

B) The IDE is really not that difficult is applicant has shown sufficient efficacy. When you consider the long pre application process , it really is beyond belief that they are almost starting over wit ha 1700 page submission.

C) What I can tell you is that if the paperwork is not correctly split into the various sections as laid out by the FDA it will be rejected again.

D) I'm very close to some who have fronted panel at FDA in the radioactive medical device field, for a PMA. And also obtained CE mark for same.

Expert - no. A little more experience than most HC posters - probably.

Time and again, a few of us have taken the trouble to post meaningful critical analysis. Others can take note and do their own research, or throw brick bats around. The choice is theirs.

Frankly, apart from a special belief in the management of OSL, many posts do not attempt to debate the company, the medical research, the regulatory aspects.

But, just for one minute lets assume the CE or the IDE will be forthcoming at some point in the future. So this opens of the possibility of commercial sales. Which brings us to the next hurdle. Have any HC posters got any ideas of how many years it will take to build a viable and profitable business?