Helius Medical Technologies Inc HSDT

Healthcare Medical Devices

Helius Medical Technologies, Inc. is a neurotech company in the medical device field. It is focused on neurologic deficits using orally applied technology platform that amplifies the brain’s ability to engage physiologic compensatory mechanisms enhancing the lives of people dealing with neurologic diseases. It develops, licenses, or acquires non-implantable technologies targeted at reducing symptoms of neurological disease or trauma. Its product Portable Neuromodulation Stimulator (PoNS) is a non-implantable medical device, inclusive of a controller and mouthpiece, which delivers mild electrical stimulation to the surface of the tongue to provide treatment of gait deficit and chronic balance deficit. PoNS Therapy is integral to the overall PoNS solution and is the physical therapy applied by patients during use of the PoNS neuromodulation stimulator. PoNS is used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only.

NDAQ:HSDT - Post by User

Helius Medical Technologies Inc

Bullboard Posts

Comment by miningfundion Jan 30, 2019 1:28pm

123 Views

Post# 29297178

RE:RE:Information for FDA - why the timing?

Thanks prokofiev, you make a good point: it seems that the FDA is requesting more qualitative, not quantitative, information which takes more time and may be more sensitive to the approval process.

prokofiev wrote: I am by no means an expert, but my guess is they have to re-tabulate, re-analyze part of the existing trial data. To put it all in contect, these FDA submissions are 2,000-3,000 pages long... So making sure there is not a single mistake and that everything is submitted properly is crucial to minimizing the possibility of another delay. This is why it will take some time for Helius to respond properly.

Prokofiev

miningfundi wrote:
Management: “We believe we have the data and information to address FDA’s questions”.

Prokofiev: I had posted last week that I expect Helius to resubmit its data in the next 2-5 weeks, but I believe pushing this out by a week to be more realistic. Therefore, my new estimate is 3-6 weeks.

If management has the data and information, why should it take 3-6 weeks to get it to the FDA?