Member Info for Jimmybob

I work in the medical device sector not COVID related but elective surgery products. Approvals have been taking much longer due to COVID. BSi have been performing 2 stage QMS reviews the first one are remote but they won’t issue a certificate without an on site review. Everyone to queuing up to book their and other Notified Bodies time. On top of that there is now new legislation coming in in the form of the EU Medical Devices Regulation. This is such a busy and complex time and so I am not surprised GDR are struggling on timely approvals everyone is. They seemed to have got some product through the process so must have a good relationship with their Notified Body or are getting an expedited review for being Covid related? JB

So here is my experience, I was against rainbow chasing COVID stocks at the deep misery of the crisis. Then I talked myself around that the way is to find and invest in these stocks to save the world?? Then my mate mr big bench was in here whom is a somewhat shrewd investor was in so a put a few quid in. I now have averaged down a few times but somehow feel we have high expectations raised by the company but they are yet to deliver and manage us PIs ? Lets hope they start to flow news and deliver. We don’t know what the future holds and what the window is for this company but they need to get a wobble on! JB

Are you reading words or between the lines? Obviously you have a different interpretation to the market? I topped up today to average down but didn’t see much positive about the RNS? It was a placeholder at best? JB

46p!!!! A friend of mine lost a fortune on this one 6 figure sum. Was a slam dunk to get FDA approval but.... we all know what happened! JB

I have held since 46p. Not far to go now;-((

Expectations were high for transformational news on approvals, orders and perhaps sales. Hopefully the big news will come soon. JB

I got a few more myself let’s hope there is more news to come and this is the only the start of the news flow. JB

You cannot sell a product without the approval and certification of both the dossier and manufacturing site, an order is not a sale in this case. JB

Am I reading this right in that we only have £1million of indicative orders of our main product? JB

WHO preauthorisation approval to do with applicability to UN tenders, so all good and relevant progress! JB

It’s not the WHO that grant the approvals or do reviews, it’s a relevant Notified a body that Genedrive contract to do the reviews. For example in the UK many companies use BSI, in Europe many use TUV sud, etc. The notified bodies grant the approvals! JB

This means that the product dossier is awaiting review and approval by the relevant Notified Body and that Genedrive’s manufacturing site Quality Management System is awaiting desk review by their Notified Body. During COVID Notified Bodies are doing a 2 part QMS review. First part is a desk review once passed the Notified Body will book an on-site review, these approvals are critical for product and manufacturing site certification. Hope this helps? JB

It’s JP I would worry about he has a track record of emptying shareholders pockets to line his own through his trading plans.

Daylight light Robbery mms taking out a stop. The share price soon recovered to high .5s. I could not buy early doors but manage to top up, missed the low but got .578. JB

So the head and shoulders pattern detects the mud blockage? You charters are very cleaver this will be back over .6 in no time with a run up over 1 with the WN spud. Is your chart in agreement? JB

All good Big Bench, don’t mention Sou or Lion both in bottom draw. Got a small holding here. I did my PhD on RT PCR some 27 years ago. In those day we have water baths no PCR machines and no taq polymerase so had to dose with fresh enzyme during the reaction which took an age, had teams taking over on a night. York company is interesting if it comes off as potentially has the specificity of PCR with the point of care instant test of an antibody. As stated though not developed yet. Have not seen anything similar? I work for a large healthcare company the key here is having data to support our unique claims and selling the unique value in the offering to displace others in the supply chain and labs that make their own reagents, with the unique selling or price points to get a foot in the door to the key buyers and reimbursement groups. Let’s hope we have it here. JB

Agreed but this is very disruptive, a simple point of care dip instant diagnostic.

https://www.insidermedia.com/news/yorkshire/aptamer-group-developing-covid-19-test
Might be of interest? JB

Hi, I don’t want to imply that there is not value in tissue banking or allograft options but wanted to check before I invest is this soley a human allograft tissue banking company? Or is there more, the companies intellectual property also talks about processing pig tissue for human use? Kindest regards, James

Yes but those funds have been used to purchase the assets, that’s the Backbone business model here! JB