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Caerus888

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12/02/21

09:54

Post #: 50921781
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Originally posted by Quiltman: ↑

Good News/Bad News/Ultimately Good NewsSo our mate Stewart had made the following reply to Patrick:

Hi PatrickNo worries - please do keep bugging me. I do have an update as well as a bit of a confession. I'm afraid I rather misunderstood the information provided to me by the manufacturer regarding the EUA delay. Apparently there was an issue with the cartridge they had submitted to the FDA and they had to revise it. This meant they had to redo their data collection process for the revised component.... for all three modalities.The upshot of this is that the EUA will be delayed by ~ 1 month.I can only apologise for inadvertently misleading you.NanoDX are working flat out to collect the necessary data and then should be back on track.In the meantime, TPS - our partner for NanoDX - have an alternative solution to provide rapid RT_PCR testing. I've attached details in the slide deck. This may be of interest for the wider COVID testing environment, perhaps complemtary to the NanoDX solution?So unravelling this :

1) Explains delay, faulty cartridge. Nothing that can't be fixed, In fact looks like it has been, and data is being re-collected.
2) The issue and delay has nothing to do with SE1. Ralph must be pulling his hair out !
3) The suggested timeline, delayed by 1 month. Question is from when - we can all have a guess at that, but I would be hopeful we are already a couple of weeks into collecting data for the resubmission.
4) It also shows Stewart is an out & out salesman for TPS, he'll sell whatever he has to sell ... so we need to be careful what we glean from him.

In a nutshell,

NanoDX have had a major issue with the cartridge, it has meant they have had to re-collect the data with the corrected cartridge ( this is standard, submitted data must be from the final mass manufactured product, not a prototype etc ), EUA should be submitted soon with the new data. Then we can finally join the dance.

Expand

Thanks Quiltman.
Let's hope the 1 month delay is from maybe a week before the Quarterly Report which was 28th January. So Monday 22nd February looking possible for submitting to FDA - and a nice fast positive approval.

Can't wait to see what the market cap of Sensera is in a years time - with a number of sensors being sold for use in many products.

The above are my own personal opinions and thoughts - do your own homework before investing.

Last edited by Caerus888: 12/02/21

SE1 Price at posting: 7.1¢ Sentiment: Buy Disclosure: Held
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