Hi Quiltman,The benefits & dis-benefits of the pandemic & Health...

Hi Quiltman,

The benefits & dis-benefits of the pandemic & Health Tech!

There have been delays in FDA approvals during the pandemic & also changes to rulings with COVID being a priority.

As an example, I am invested in a diagnostic company & we had delays with the application, it was a little complicated as to which path to application for approval for a test, 510K or DeNovo (where there is nothing comparable already approved).

The FDA had changed their pre-application Advice rules & criteria in the midst of this & so the company had to file a different application which was 513G, so had to be re-submitted. This is across the board, so you can’t blame individual companies for FDA delays giving COVID approvals priority.

We did finally receive FDA advice for DeNovo pathway for FDA application, so things are actually moving for FDA approval applications for Medical Devices. It can be a little more complicated for some devices, but better to take the time to get things right with the FDA in the first place including all the efficacy data necessary for FDA approval.

CDX as Niall spoke of in the interview (discussed on other thread) is ‘USA Centric’ being largely based there & referenced the recent announcement of OTC listing for USA market, but with global opportunity - I thought it was interesting he mentioned India, massive market in cardiovascular/diabetes & a huge Pharma industry.

Forgot to mention that in my post on the other thread. So the China presence for Mobvoi & manufacturing, I think we will clearly see soon there will be a lot more to the CardieX story unfolding globally particularly in the USA. Thanks again to @hedrox also for your recent post on investment in Med Tech, interesting!.

These recent articles & videos have just confirmed for me my thoughts on CDX & where we are heading…in the right direction!

Also, I will be using this horrible Red market to top up on my holdings as I did on another bio investment last week.

It is a good opportunity & other health issues besides COVID are not going to go away, in fact worsen with post COVID infection complications, cardiovascular disease is just one of the effects of Long COVID.

So these things that occur with global markets may look like a disaster to some, (reference the 2020 big market fear sell off at the beginning of the pandemic & then a big rally), I am certainly going to take advantage & wait it out.

GLTAH