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Jgriffin

278 Posts.

44

06/09/19

17:20

Post #: 40343513
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Originally posted by Galilee13: ↑

The approvals required by a manufacturing facility are completely different and independent to approvals required by a particular device.

For example GMV were getting there products manufactured at third party facility. And the GMV factory in China could manufacture other products on top of the prizma and patch.

Now, for the GMV business model to succeed and to mass produce devices it requires scale and ALL the infrastructure and approvals in place.

This means for each jurisdiction it must have a certified factory, certified product and an IDTF facility. This also applies to any MOUs. They can't convert an MOU into a contract without all of these in place.

So, in the major markets:

UK we have CE for the factory, prizma and patch. We also have a IDTF facility. So in the UK we are good to go! I'm not sure if GMV could use the UK IDTF facility to service other parts of Europe, a question for the company.

In the US we have FDA for the factory, FDA for prescription only prizma (OTC can't be to far away) and FDA for the patch is expected 1H20. We have a huge IDTF facility to service this market.

In China we only have NMPA for the factory. Still waiting for NMPA for the prizma and patch. I have no idea where the company is at with a Chinese IDTF facility. But it will need a massive facility.

Keep in mind the factory can produce 1m units a year. So GMV is building up the infrastructure to mass produce and service on a very large scale.

This all takes time and money.

So before GMV can convert an MOU to a contract and thus before it can start mass production it MUST have in place an approved factory (tick), an approved product and a IDTF facility to service the market.

Expand

As far as I know, we are waitng on CDFA approval so the IDTF can be set up. Just to stir the pot, remember all MOU's are still current as per the company update unless announced.

GMV Price at posting: 8.1¢ Sentiment: None Disclosure: Held
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