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Re: Dr. Mugs post# 32767

Saturday, 11/27/2010 1:53:08 AM

Saturday, November 27, 2010 1:53:08 AM

Post# of 59551
Mugs ..As I stated in my previous post that some NSE letter read more like AI letter ...and may require clinical or animal data for re-submission.

Page: 15
https://www.orthoworld.com/site/orthosupplier/omtec/larson_handout.pdf

Now the million $ question ..Do we need to have human clinical trial ...in that case we can not afford our own ..we will have to do some kind of partnership ...or massive dilution to fund these trails ...

Base on available information (clinicaltrial.gov) ...human clinical trail are required for devices like implants , mammography , disease detection ..etc ..I could not find any device similar to DVIS intended use went through human clinical trial ...

But I am not ruling out anything ...only thing that probability of human trail is very low ...

Worst case scenario is animal trail ...We will know the answer in next 2-3 weeks ...

KKG