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So what are they trying to say, the

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Helius Medical Technologies, Inc. Announces FDA Has Granted the PoNS Device Breakthrough Device Designation for the Treatment... GlobeNewswire Inc. - 5/12/2020 7:05:10 AM
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UPDATE -- Helius Medical Technologies, Inc. Announces Publication of its PoNS™ Registrational Clinical Trial (TBI-001) in T... GlobeNewswire Inc. - 4/30/2020 12:02:09 PM
cash_cow1   Monday, 12/30/19 01:44:10 PM
Re: tykundegex post# 154
Post # of 171 
So what are they trying to say, the patients were reaching some of these goals without the use of the PoNS neurostimulation device. The difference is that all of these patients didn't start the PoNS neurostimulation not until after 12 months after their brain injuries, then they started the program. IMO, I guess the FDA wanted half in the study to be treated with the PoNS neurostimulator device and the other half to be treated with Physical Therapy sections not using the PoNS Device. Make sense. Next complete a trial study of Patients whom have completed Physical Therapy and enroll them into the PoNS neurostimulator device Clinical study and see how well they benefited from using the PoNS device after going thru PT. What percentage of patients benefited from the PoNS Device, and what percentage of patients did not benefit from the device.

Then on the other hand I can see while Helius Medical Technologies Inc sent in their NDA for PoNS Device because they use Patients 12 months after their injuries and not before. IMO the reason why the FDA did not have enough evidence to support Helius study of the PoNS. Maybe if they would've started the study from start of traumatic injuries mild to moderate injuries, in both physical therapeutic to using the PoNS Device and a study of Patient using PT without PoNS device. Helius Medical Technologies inc would probably have an FDA Approval for the PoNS neurostimulation Device.

Please, Correct me if I'am wrong.

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