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There is some excellent reattach uncovered on Twitter by Marik and covered by others including the ethical tout which some others have shared on this forum over the last two days. The dose evaluation is guided by the CTCAE guidelines. Basically it says
Therefore, for a 50% increase, the event which occurred during this trial would likely have been a ‘grade 1 event’:
"Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated." As per the CTCAE guidelines.
Affirx has been on there for the last year. In USA they cannot use the trademark Affidx or Affirx. There is another trademark in existence that the office decided is too similar. We’ve know that since august last year.
That’s good I haven’t sold anything just shared my FOI response. I hope you get a response TK.
I am LTH in Avacta for the therapeutics. The LFT was always a bonus for me but on point of principle I have take action on the lack of support for the British diagnostics industry as it galls me.
Thanks for sharing.
I like what he said at the very end of the video about Avacta having the integrity to pause the LFT sales while they remedy the accuracy. He said management like that he will serve us a good stead in the long run .
Dear Ruth
Thank you very much for your kind words of encouragement and for this very helpful information which illustrates the UK governments hopeless approach to UK diagnostics. I hope to secure a Westminster hall debate soon and this will be very helpful for the points I intend to make. Please do not hesitate to forward any further information you may uncover.
Remember the FOI request I submitted in Nov. After chasing three times in December and providing the link to the review on the government website because they said they didn’t know what review of LFT s I was enquiring about and then they needed another 20 days to answer the request.
Here is the main response
“ Response
Please see below for responses to your queries:
How many staff are reviewing Lateral flow tests for use under the new regulations in the U.K?
There are five full time equivalent scientific advisors reviewing applications for approval under the Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (CTDA).
How many tests have passed the review and how many companies are currently waiting for their review having meet the deadline of September 1st and paid their fee?
21 companies applied to CTDA with lateral flow devices prior to 1 September 2021. As at 17 January 2022, none of these 21 lateral flow devices have been approved under CTDA. Lateral flow devices from 13 companies are currently included on a temporary protocol (Medical Devices Regulations 2002: protocol -
1
GOV.UK (www.gov.uk)), which means that they can be sold on the private sector in the UK.”
From the info in the link in the update on the recent RNS , I understand the FDA are working with the manufacturers so they can still approve the tests without having to go through the whole process again. It refers to omicron decreased detection as being addressed.
If you follow that link , there is lots of information.
FDA says omicron has S and N mutations. .
A nine-nucleotide deletion in the N-gene, spanning positions 28370-28362, results in an N-gene drop out, also referred to as an N-gene target failure (NGTF), where the genetic target that covers the portion of the N-gene where the deletion occurs fails to detect the virus.
There are lots of test makers that are experiencing the same and the FDA is pausing the sale. Better for Avacta to make that decision.
The FDA is working closely with test makers to ensure that they can address the issues and still get tests to market.
I think the antibody tweak will get AffiDX back on sale asap to address omicron .
I think they will separately develop a second generation test for both S and N and include detecting flu in the test for the coming winter season.
Brilliantly informative thread. Thank you all. What the board is intended for.
From what I can glean from the Elisa section on the Avacta website that stringent regulatory processes (particularly FDA) might mean it was the simplest way forward rather than using two affimers.