Member Info for rbr08

@Inphobe: I emailed genedrive/Walbrook about the UNICEF contract, and I was told:
"We’re not allowed to release unicef info without their permission, which we have not yet received."

Yes I would think the New Mexico lab results would be included.

Walbrook's exact response to me, just last week, on this topic was:
"The FDA uses company supplied data for EUA listings."

For FDA EUA approval, there is no requirement to send sample tests or tests for in-house trials. The FDA assess data provided by the company (for which I believe US lab becomes key, which we have) . This has been confirmed twice by David and Walbrook.

I'm not sure that date is correct. Will be interested to know where he got that date from.

I'm not sure where June for an update was taken from. 30 June is end of financial year but there is currently no date planned for presentation of full Yr results which will usually be a few months later (after summer).

Go ahead, send him an email. I have emailed him many times in the past.

@Preefty, sorry about the confusion. I misunderstood what you were trying to explain. Thought you were implying there was a new process, rather than describing the type of tests that were approved. My bad!

I know about this page. But you said that new EUAs are direct to customer. What do you mean by that?

@Preefty, what do you mean new EUAs are now direct to customer? Where did you read this?

I have asked in the past and I also asked Walbrook yesterday - but no reply. I believe GDR are not clueless about FDA. Don't believe for a second GDR have not been having comms with FDA (they even stated this back in Nov 2020 presentation). They just would not advise investors (or PIs) what is happening. If anyone

In fcat, never mind my last post. I think I initially mis-understood that comment. Though it is still unclear to me what is meant by it.

@CWalsh - thanks for reminding me of this. I just had a quick glance through as well as some of the others previously, but Ive never seen genedrive ask/have a question answered.
What struck me in this one was the comment that Dr. Timothy Stenzel made at the beginning .Its not very clear to me, but I wonder if this extraction issue has any part to play with GDR?

"I did want to make one comment and that is we still recommend that any
molecular comparator for any submission be of high sensitivity with an
extraction step and that it be EUA authorized as used in the developer's, in the
sponsor study.
If it is not EUA authorized or if there is an alteration to the authorized method
it will cause a significant delay in our review because then we'll be required to
bring in a molecular review group to look at the method that you use. "

@bigbench, honestly no disrespect but lets keep comments constructive and not on repeat. If May, then say what facts you have to support. But it does not read well when every month you say the same thing.

@jayhayes - I agree to be asking questions. I've emailed a few times asking for answers, but good to see others doing it as well. I have stated to Anna in the past, freq comms does not equal x2 live presentations per year. Nor does it mean it has to be a sales related RNS - we have other channels e.g. Twittter, LinkedIn, emails. Its more of informing the market as to how things are progressing.

Hi Anna

I’ve got a Couple of questions you can answer for me.

1. Why haven’t we heard anything from the EU dea from last year.
2. The poc what’s going on with that?
3. Are we still manufacturing the beads? If so how many have been manufactured?
4. Are Beckman still in frequent contact with Genedrive and are they actively pushing for fda.
5. As a share holder who holds significant shares. I would like to stress my concerns over the lack of communication.

Jamie

Sent from my iPhone

In my opinion, anyone who responds to this, is simply guessing. The better question to analyse is 'What are the factors that influence the growth in share price/market cap and can you safely put a timeline on any?

Where we are now:
1) HCV ID Kit - Unicef agreement in place. Just awaiting official announcement, once permission is granted.

2) MT-RNR1 ID Kit - it should definitely be a part of the PHE framework tender we are now a part of.

3) BioPlex Pathogen Detection - new distributor MountainHorse will be opening up greater opportunities for sales conversion

4) 96 SARS-CoV-2 Kit (PCR) - we now have Indian approval so, given roughly 2-3 weeks to sort out import paper work etc, we should be getting ready to ship products , if not already, given the dire situation their in India at the moment (a very unfortunate time now because no life should be treated less than any other).

Beckman Coulter is now 2 months into their full-on marketing. What we can see is continual updates made on their website - providing more information and scientific data to support the product. This does not say much for sales, but what it does say is that they are taking it very seriously and for a large organisation like BC to be in this mind-set does say something. We await sale conversion info. And yes, we are all waiting to see when FDA-EUA comes through.

5) 96 SARS-CoV-2 Kit (PCR) Biomek Automation - still awaiting an update on the status of this project

6) POC - awaiting update in Q2. As we know, the PHE contract is open to allowing new and improved products in lie with the framework to be introduced. What does this mean for potential POC inclusion once CE approved - we wait to find out!

Sunday morning recap!

@Invest4theLT: yes these seem relatively new in terms of being on the page. But in the March presentation David spoke (and had a slide with the results) about the evaluations of our tests done at various locations.

1) It means we have a contract award from UNICEF for an undisclosed amount under a Long-term Arrangement. This looks like the start of a very important period for the business going forward (tied in with the other products all coming together nicely).
2) It was published 20 April 2021
3) Yes this should be RNS - it is price/ market sensitive info.

Great find @Invest4theLT. Lets see what is said.

I was told the company has been in a closed position since summer 2020!! Take from that what you want.

Its a good thing for us. IT shows that one or more of our products submitted under the tender is of interest to PHE. Hopefully further details will be released via an RNS and that we see some sales conversions in the short-medium term out of this.