InvestorsHub Logo
icon url

longfellow95

03/26/21 6:58 PM

#365124 RE: Lykiri #365117

That's great news, Lykiri.
It shows, for sure, that despite Covid restrictions, UK Specials is functioning, though probably in small numbers and with some painful delays for patients. Quite a few patients from UK and abroad might be in the fortunate position of not having to crowdfund. And these may be getting treatments that we will never hear about.
So there is no real way of calculating current numbers receiving treatment.
Though realistically, it will be small right now, but with the potential for much greater numbers, as Covid restrictions are hopefully eased, and Sawston is licensed.
If this gets UK approval, I'll say what I've said before, no marketing will be required.

And on when the NICE STA gets restarted: That was a nice little hint from your reporting. I would expect NICE to get their submission and restart more or less the same time the formal MAA goes in to the MHRA. And both appraisals to run concurrently.
Then give it ballpark six months from then.
So maybe 3 months plus 6 months.
But don't hold me to that!

I expect you are keeping one eye on developments with Laura N also.

Regards.
icon url

Doc logic

03/26/21 8:12 PM

#365133 RE: Lykiri #365117

Lykiri,

Seems like Joel being Dr Ashkan’s only patient using DCVax-L right now might be a clue with regard to Flaskworks validation process more than Specials Program but then again I might be getting ahead of the process thought wise as is often the case. Best wishes.
icon url

VikingInvest

03/27/21 12:10 AM

#365156 RE: Lykiri #365117

Definitely sounds like Dr. Ashkan might have said things that at this time is not public information and might have been told in confidentiality. Likely not something he would say if the indications were not positive. This part to me is the best news in a while regarding the expectations for TLD. Add the ramp-up at Sawston with all the new hires and I am adding more Monday.

Thanks for the info.
icon url

eagle8

03/27/21 6:40 AM

#365163 RE: Lykiri #365117


Thank you for sharing Lykiri.

Great to read Joel is doing fine!

I also liked this part:

-The research is so promising that the National Institute for Health &
Care Excellence, (NICE), are currently setting up an appraisal
committee with researchers, clinicians and the Brain Tumour Charity to
discuss the treatment’s suitability for full NHS regulatory approval.



GLTU
icon url

exwannabe

03/27/21 1:23 PM

#365184 RE: Lykiri #365117

-The research is so promising that the National Institute for Health &
Care Excellence, (NICE), are currently setting up an appraisal
committee with researchers, clinicians and the Brain Tumour Charity to
discuss the treatment’s suitability for full NHS regulatory approval.


The NICE opinion process is public (though some confidential information will exist within it). The NICE review was suspended 2 and 1/2 years ago.

The NICE process is typically almost a year long. That is why they try to start it before the RA submission.

Kind of points to no plans for an approval this year.