Member Info for clark8004

It states 2021 as submission date which I presume to be when BC added there shoulder behind the application. It’s active and as you have pointed out meets the current assessment criteria. Hopeful that this is the case and lands soon. GDR is due a change of luck so holding, hoping and watching with interest.

Status: active

@preefy this is what I thought was the agent to support the application?

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
US Agent:
Michael Van Der Woude
Emergo Global Represenatation
2500 Bee Cave Road
Building 1,Suite 300
Austin , TX US 78746
Phone: 512 3279997 Ext
Fax: 512 3279998
Email: USagent@UL.com

Guy you holding GDR shares or just bashing them?

I get the frustration and anxiety if your underwater but surely incessant ****ging is counter productive.

Anything good or positive to add? Serious question

Doesn't sound like our test. Anyone with technical knowledge might verify

@Sally. Do you not think there was a reason ICMR approved GDRs test given they had previously given them the run around over the 3 versions of the test last year?

Their current testing strategy (cheap At best) has lead them to this point. Last time I checked the ICMR approved PCR list we were the only UK company? Hepatitis is also a huge burden on the Indian government. The Genedrive POC one stop diagnosis has massive potential to cheaply diagnose early enough to medicate rather than chronic cases multiply cost with complications? I hope this massive market does have potential for Genedrive?..

Didn’t DB mention they were appointed a case worker?

There were some registration updates on FDA page so there did look to be progress

Maybe that was the call forward point when they acknowledge the application?

Like make final updates to their company website etc :)

@preefy. Recon that be the case or the would be storage and batch sample issues.

Be nice even if the called forward for evaluation date was disclosed.

I got the idea from the presentation that DB had tried everything and to no avail! Hence the reference to a separate BC application?

Seen this and thought be nice if someone with in roads to Genedrive emailed them asking if they intend to submitted any questions

Save the Date:
The FDA will also hold a virtual Town Hall for test developers to help answer questions on:

May 26, 2021 from 12:15 pm - 1:15 pm Eastern Time

For those transfixed on SP draw yourself up a chuffed chart

30 Days could see a few material RNS over this period?

Watch it still drop a few points at the open! Rotten...........

Like the logic but not sure DIVOC are big enough for 1 given they current possessing capacity?

Kanva has been public with the Genedrive collaboration just wonder if BC are now exploring other routes into India hence the import/export paperwork application. I know the Indian government would rather all contract through them which ticks their India Nationalist approach?

I think the 1M did go to DIVOC and they will still have a big chunk left unless they have bought a shed load of i7 Biomecs?

Doesn't seem to be any issues? Dave77 where was the tiff idea from?

New website still advertising 6 hour RT PCR test Turn around with the best in the business claim?

I think DIVOC might well be the 1M sale but suggest the ICMR delays could have been the sticking point. Let’s hope they do come back for more, although leave that to BC!

Didn't someone post a link to GDR site showing the HCV kits for sale?

Stating the obvious won't exactly accelerate resolution

DB has a sales background and BC sell in big handfuls. FDA is the Achilles and I imagine the company and BC are applying any and all influence to gain EUA. All sales will no doubt be pending EUA hence no updates. As frustrating as it is until news lands the SP is vulnerable to derampers, trolls and impatient investors bad mouthing their own hard earned :?

I remain committed and confident that DB will pull it off!

Intra-day RNS?????? Hhmmmm I can safely say the next RNS will probably catch us all off guard and not be as all predict . Probably the WHO approval or POC CE marking. The market wants FDA and Sales! So do I lol.

Agree with all but getting bored means giving your money away to the patient

Closer to news today than we were yesterday lol

FDA and true potential will be realised. If not then POC and AIHL and maybe HCV will all feature in Q3!