Member Info for RiskIsReward

I think they are going to wait for the current application.
Although DB sounded bit down during presentation he is confident of approvals as our application and data is correct and we did get our data reviewed from Beckman before submitting it.

Our application submitted to FDA is not based on biomek i7. The current application pending application only deals with Beckman's RNA extraction and for our bead to make it one step pcr test.
check the documentation on genedrive website for instructions to use which was submitted to FDA, no mention of biomek i7.
https://www.genedrive.com/documents/ID-COV2-IFU-USA-V3.pdf
if we were to be considered as high throughput test, then we have to resubmit our application and we would be back in queue again. So DB is patiently waiting on this now.

Watch the presentation carefully, DB does mention about this.

Q24: David has a history of making predictions that have failed to deliver, Examples: 1) 22/05/20 "The Company aims to record first commercial sales in June", 2) 22/10/20 "The Company is targeting end of the calendar year for completion of preliminary product evaluations with the release of the final CE marked system in Q1 2021". 3) November 2020 "Indian approval is very near". So how can we place much confidence in what the Company has to say?

The Board of Directors are responsible for making market announcements and forecasts, and the data that supports the prediction of future events is reviewed by the Board. When the Company provides timing forecasts, they do so using the best information available to them at that time. When such forecasts are made public they are normally described as targets/ predictions/ estimates, as they are forward looking statements. It's entirely up to investors in their decision making as to how much confidence they place on these forecasts or the forecasting of the company.

Missed every deadline set by himself and blaming investors for having confidence and believing his words and buying the stock. Really poor excuse.

Q47: POC has been delayed to Q2. Can you refine your expectation, ie is it expected April, May or June?

The launch date is an estimation. The Company commented on a three month delay so it will be towards the end of the quarter.

They had a chance to update the market early but choose not too, DB was hiding stuff till last minute which is not good. No wonder market reacted sharply.

I always state facts.. You have to check my history..
lol - happy to post more stuff and ramp it if it can move SP up, but it doesn't work that way. I have to admit that i tried that in the past and doesn't work.

The Good thing with WHO is we must be right on top of the queue..
it features 7 pages now compared to only couple pages when we are on it last year.

with out FDA EUA Approval*

Out of 91 labs test that on the FDA site which can distribute test with EUA only 26 are approved.
Out of 26 approved only 2 received approvals in 2021.. We are not the only ones waiting in queue for FDA.
Same is case with WHO - not a single PCR test was approved this year. (there id additional application number added to site now)

What do you recon is a good entry point is?

I hope it is not true.. If Budd is gone GDR are in a massive problem..

IMO - Agree unless there are sales or contracts signed by End of June

Fund raise would take time and its not instant loan that you get from tesco.

Q24: David has a history of making predictions that have failed to deliver, Examples: 1) 22/05/20 "The Company aims to record first commercial sales in June", 2) 22/10/20 "The Company is targeting end of the calendar year for completion of preliminary product evaluations with the release of the final CE marked system in Q1 2021". 3) November 2020 "Indian approval is very near". So how can we place much confidence in what the Company has to say?

The Board of Directors are responsible for making market announcements and forecasts, and the data that supports the prediction of future events is reviewed by the Board. When the Company provides timing forecasts, they do so using the best information available to them at that time. When such forecasts are made public they are normally described as targets/ predictions/ estimates, as they are forward looking statements. It's entirely up to investors in their decision making as to how much confidence they place on these forecasts or the forecasting of the company.

He is still no giving reasons for delays.
like EU deal.. ICMR India approval.. what transpired since november presentation to last week one...
What is the case worker feedback? what is stopping to sign the dotted line for EU deal? he needs to open up otherwise hard to see this stopping.
Some people dont like me stating facts over and again.. they think i'm deramper..
If i dont do this all the rampers would be all over this calling.. flight taking offf.. imminent approvals and spout all BS with all the nonsense numbers...

I said this couple of weeks ago and saying this again, this is a high risk stock offers huge reward if things fall in place.

In November presentation DB said...
1. Approvals are around the corner and they are in constant touch with case worker at FDA and ICMR
2. EU deal would be signed in December 2020, sale and revenue to materialise in Q1 2021
3. POC CE marked by Q1 2021

But now after 3 months I’m last week presentation
1. No mention on of India ICMR and Given up on FDA
2. EU Sale still not signed
3. POC delayed to Q2

How on earth any investor would continue with Share, unless some thing material land this won’t move up and a very good chance of keep sliding down..
It is disaster last week and unfortunately would continue that way.

From past history of GDR I highly doubt the EU deal would fade away like the £1m indicative orders June last year... people need to think why would it take 5 months to get a deal done in a pandemic? Question yourself? DB is surely hiding something...

DB clearly mentioned during presentation that we did submit bids for AIHL, HCV and high throughput COVID Test to PHE as part of the 22bn framework which runs for 4 years. suppliers were told to keep everything confidential. I hope some good contracts would land soon around this soon.. watch out for this.
FDA would not here anytime soon.. out of 91 lab tests, only 26 were FDA approved out of which 2 were approved in 2021. There are huge queues for this..looks like we are very late to the party.. same is the case with WHO

Very well placed for a cheap take over? at £2 or £3?
BC can then push for FDA/WHO easily as we are struggling to understand the regulatory process.
DB kind off hinted the same at presentation

worst week for GDR.. doing more damage than the vacine news..

where are people gone...

POC is not ready and was not submitted