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It looks like it will take a bit longer than NCYT did but that could be due to the urgency around Covid at the time. I have no doubt both FDA and WHO will come, hopefullly soon!
WHO preauthorisation approval to do with applicability to UN tenders, so all good and relevant progress! JB
@I4LT I was thinking the same, would make sense
From the WHO website about submissions:
‘An assessment of the manufacturer’s QMS documentation is a critical step in the reviewing of a SARS-CoV-2 EUL submission. Based on this assessment, WHO decides either to continue with the review of the submission or to request further documentation, or to terminate the application at this point.
The decision to proceed with the review process will be made only if there is sufficient objective evidence that the applicant is the manufacturer, that there is evidence of an adequate QMS in place and that the required manufacturing capacity exists.
The quality management standard ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes is considered a benchmark in quality management for manufacturers of IVDs by regulatory authorities throughout the world. WHO base their requirements on those identified in this internationally-recognized quality management standard.’
Maybe the recent QMS renewal was driven by this.
Thanks for the insight JB. Feel a little guilty now complaining about time taken, well pleased we can see evidence of wheels in motion though.
*Crawls back into hole*
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
That's great jiimybob, so WHO have the info, we are waiting for then to review and approve unless they require further information?
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
Yeah I'm no expert in these things, but I tend to agree that we are in the stage where WHO are waiting for evidence to be submitted after the pre-meet process.
I admit it's a little frustrating since I would of thought that we'd be in position weeks ago but I'm just glad to see SOMETHING after weeks of nothing.
My guess is that we are probably still a few weeks away
from an approvals based RNS and then I hope the sales flow. Time to crawl back in my hole for a few weeks!
Now that is curious. The WHO document says the GDR test is "awaiting submission" for both the dossier review and the QMS desk assessment. It would be nice to know precisely what "awaiting submission" means. Quite likely it means that GDR have advised the WHO of their product and of their intention to make a submission of relevant documents and a test kit (so it is on the list), but GDR have not yet submitted these to the WHO.
ST
If I’ve been found out, count the number of people who’ve posted here today. Total their posts. I do NOT have the highest number of posts, nor do I have to post constantly to defend my view. It seems you have issues accepting other people’s views though. Your a proper keyboard warrior.
Go a step further. Separate the sentiment in each post. Total the two sentiments. I guarantee your in a minority. That my friend is called sentiment analysis. Look it up, it’s a very interesting topic.
Yeah, I’ve been found out. Lol
Are you a kid, oh I’ll go on the ODX board and post **** there. Be my guest. I wrote to Ethio today the CEO screwed everyone over. Does it look like I’m afraid of losing my investment there? Oh and Ethio also thinks the CEO screwed us over in ODX. Write all you like till your little mind is content.
ST
It was only a matter of time, I always thought you we’re a delusional twit with all the ignorant yet subtle ramps.
Odx I’m in. Never hidden that fact. Am I losing sleep over it? Nope. Do I have to go on ODX and lie about it? No. Look at my most recent post. I saw the mologic test. Asked about it there, seems it’s not ODX, I closed the case. Finished. No BS ramps to convince people it could be us. That job is reserved for you.
The day you learn common sense and spit out that bitter delusional pill you always have in your mouth perhaps you will feel better for it.
Difference between you and me, I couldn’t give a hoot if you post on the ODX board. If you post lies you will be found out. If you stick to the facts and say ODX is **** genuine people will still appreciate you for it.
I like how you and your ramp crew are slowly running for the hills here. You’ve been found out.
Quite good that Safy is deramping here as his ramping in ODX, where he stupidly believed the placing would be at a premium to the share price at the time (what a complete tool for even thinking that let along posting it) , killed the share so his deramping here is just what GDR needs :)
Once you get FDA , it does not take long to get approval in India. See NCYT (Novacyt/Primerdesign) on the list. They got their FDA 20/03/2020 and India 26/03/2020. This explains why genedrive is not showing on the India application list. They're taking a different route to get to India via FDA. Could they have done both? may be
CE Mark seems to have been dished out without much validation which is why we have so many cr@p tests out there. The CE Mark does not hold a lot of weight it seems. It certainly did not make a difference SP wise for GDR and ODX. Both dropped on CE approval.
About 1 month ago, i read somewhere that the FDA approval will not be as easy as it used to be as so many cr@p tests were in the US. Esp the antibody tests which had little accuracy but were on the market in the US.
Depending on when it was submitted, i would say in good time, it should be approved soon and we'll see the ball rolling then. Like TS said, they would not wait to line up buyers until the approval arrives and they would have done that.
ITS ALL ON THE fda - once we get that, we move forward.
I would have expect sales in Africa with the CE Mark.
As for WHO, not even submitted the application it seems. Not a target for GDR at the moment it seems. Again, why have they not submitted an application, God knows.
PS, for ODX, we saw an approval on this site a day before we got the RNS. It was on twitter before an RNS notified market.
ST
I feel as though you are missing something. An application needs to be submitted before they would want further information etc.
We are not Roche so it’s irrelevant really what their status is.
Well, It seems to be a different Roche test waiting for approval. The Roche test that has been already approved is a different one.
The one approved; cobas SARS-CoV-2 Qualitative assay for use on the cobas 6800/8800 Systems 09175431190 and 09175440190
The one on the waiting list to be approved; Elecsys Anti-SARS-CoV-2 Qualitative assay for use on the cobas
e 411/601/602/801 immunoanalyzers 9203095190; 09203079190; 09216928190
Here is the current approved list;
https://www.who.int/diagnostics_laboratory/200625_eul_sars_cov2_product_list.pdf?ua=1
Here is guidelines for applying WHO approval;
https://www.who.int/diagnostics_laboratory/EUL/en/
https://www.who.int/diagnostics_laboratory/200609_final_pqt_ivd_347_instruction_ncov_nat_and_ag_rdts_eul.pdf?ua=1
KD, I am really appreciative of this post. Please don’t think anything different.
This is what it says on the WHO submission webpage.
Manufacturers who are interested in an EUL submission for assays to detect SARS-CoV-2 are invited to contact diagnostics@who.int to arrange a pre-submission meeting/call. Please note that applications won’t be accepted without prior consultation with WHO.
It looks like we have only had this pre-submission meeting and now and we have been asked to submit the relevant docs based on the status updates in the link.
Or have I misunderstood it?
Cheers ST, thought I saw it somewhere
Does anyone know how long WHO approval takes?
Just to confirm, don't we get auto-approval for India with FDA so no need to continue checking IMCR?
ST please can you post FDA link as well!
Cheers ST, hopefully calm some nerves
KD
Thanks for the news. Greatly appreciated.
Can u please post a link
Sorry forgot the link https://www.who.int/diagnostics_laboratory/200707_eul_covid19_ivd_update.pdf?ua=1