InvestorsHub Logo
Followers 36
Posts 1166
Boards Moderated 0
Alias Born 03/07/2013

Re: None

Thursday, 04/23/2020 9:11:25 PM

Thursday, April 23, 2020 9:11:25 PM

Post# of 97081
3 excerpts from today's PR

New markets for our GenViro! have also been recently identified, the latest -- large businesses, Fortune 500 companies, seeking to reopen for business in the next month or two. This is perfect timing for the availability of kits.



Important quote because it indicates that they are ahead of schedule for production, i.e. it means he is confident that they can be producing kits well before September. In the next month or two, so with FDA Approval they are ready to ramp up production of test kits and his request for special conditional EUA in order to begin manufacturing kits means he is totally confident that the kits will pass the USA lab tests.


So in order to move its application along within the EUA review system, DECN removed all of the description and data owing to the individual at-home kit. And now we bring it back -- by demand.



While I've complained that DECN hasn't shared any test data with us via PRs directly, this phrase indicates that they did have test data in their initial application related to the in home test kit and it was removed along with the home application, so that's encouraging.


We also anticipate a request to direct us to conduct a donor study of a modest group of donors. We have already identified a group in Pennsylvania to make use of the Genviro! Swift Home kit. Additional testing required for this kit is anticipated to take less than a week.



They are being pro-active to speed up the test to market and with the data they have, the data that the USA lab will provide, they expect only another week timeframe to finish testing for their 2nd at home test kit, which means they could potentially have approval for both versions of the test kits by the end of May or early June, far in advance of the previous late summer projection or was it Fall for the 2nd test kit.

All of this indicates indirectly that they seem to be on schedule, do not anticipate problems in either their materials supply chain or the arrival and installation of the $1M upgrade of manufacturing equipment needed for expanded production of the test strips.

May could become a very exciting month indeed.