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NOLUPUS is it top sercret come on spill the beans
@Nolupus
Not yet, I’m very busy at work today but happy if you can enlighten us. What’s the crystal ball telling you?
Oscar22,
Have you found the link between Joan MErrill and Immupharma ??
And for Sjogren they are also at the right address.
https://omrf.org/research-faculty/research-centers/osscort/
Is it about this:
At OMRF, we run the Oklahoma Lupus Cohort—a group of more than 400 people with lupus who donate blood samples and clinical information for laboratory studies, so we can help develop new targeted treatments. We also do treatment studies for lupus patients who choose to participate in the testing of new biological agents. Some of the studies are very exciting, because they link laboratory studies with treatment assessments. Because people donate blood samples before, during and after the treatment, scientists can monitor the effects of the new treatments and learn more about the way the immune system actually works. And, because lupus is such a complicated disease, these studies may help to figure out which patients should be getting each specific treatment and what the best approach to dosing is.
Thank you, I will do my own research and let you know if I find anything interesting.
What about Avion’s submission of the SPA, what’s your theory?
Oscar22,
There is a direct / indirect connexion , I will let you find it yourself :-)
@ Nolupus,
What’s Joan T. Merrill’s direct connection with ImmuPharma or Avion?
Do you think she will be a part of the KOL’s in the US?
Of course they did, they are ImmuPharma’s sponsor. What’s your theory?
“SPA is a process in which sponsors (2) may ask to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies...”
______
“... 2 For the purposes of this guidance, the term sponsor includes any sponsor or applicant interested in SPA...”
Yes ,
It's written in the RNS
Avion submitted the SPA request and not IMmupharma .... hmm
A little adding of the dots ....
https://www.lupus.org/leadership/joan-t-merrill-md
@ Pangolin
The Centre National de la Recherche Scientifique (National Center for Scientific Research) or CNRS could be just one in Europe but how about the others and most importantly, the KOL's in the US?
@Nolupus
-Avion submitted the SPA request
-"The KOL members are Board of Key Opinion Leaders ("KOLs"), all of whom are senior respected consultants within the lupus and autoimmune community in the US and Europe.
In consultation with these advisors, a number of key decisions will now be made and next steps agreed in advance to meeting with the Food & Drug Administration (FDA). These will include:
· Agreeing the structure of the optimised international Phase III Lupuzor trial;
· Agreeing on the demographics and patient inclusion criteria; and
· Guidance on key territories where the trial will be conducted
Once the Phase III trial has commenced, these advisors will together provide:
· The support and expedition to identify and recruit the most appropriate lupus patients for the trial and;
· Promotion to patient steering groups to raise awareness of Lupuzor to lupus patients and their clinicians throughout the duration of the trial."
So what's your point here and do you know the name of the KOL's?
One of the KOL: Centre National de la Recherché Scientifique (“CNRS”) ?
Submitter SPA request: Avion
Not passed for my exam imo. :-)
https://ocrc.net/who-are-clinical-trial-sponsors/
Who submitted the spa request ?
Who are the KOL members ?
Nlp wont spell out his view to his students . He wants them to do their own work on this... but with some promting from him..... I'm too scared to ask him direct if he could just tell us all what he is alluding to.... what does your crystal say oh great NLP...
@Nolupus
Could you be more specific, are you referring to this bit?
“This tripartite Phase III protocol development approach provided thorough and detailed support for developing the most relevant clinical trial for Lupuzor™ in SLE patients. Data and results from the first Phase III clinical study were analysed and considered in detail and, as a result, a new optimised international Phase III study protocol has been finalised and is now the subject of the SPA request to FDA.”
Or perhaps you are referring to the possible size of the clinical studies or the 45-day review period?
Halfbutt,
https://www.proactiveinvestors.co.uk/companies/amp/news/908096
If one reads the FDA document and then read The RNS of the 27/07/2020 , one will see things in a new light , imo
Nlp..do you mean the 27th.... what would be the expected timeline for spa outcome.... does a date have to be agreed or is the request in progress now with a known future update
Halfbutt,
Have you read the two documents below ?
Think we need another pro active interview from Tim... on the last interview he left many of us with expectations of steady news flow and a kind of smug assurance that he new what was coming but obviously couldn't comment but it Would come out in due course...well it's now due course update time Tim... .. it's not gone down but really needs to move... its September soon !!!
Interesting paper.
f.e. An interactive process, to reach concurrence on major protocol design features during the 45-day review period,
is desirable to avoid the need for resubmission.
If only minor issues remain, sponsors can
proceed with protocol implementation, recognizing that a subsequent protocol amendment may
be needed after study initiation.
The SPA ....
Please take the time out to read the following and then read the IMM RNS of the 17/07
https://www.fda.gov/media/97618/download
Looking forward to reading people's comments ....
And an update on its expanded its pipeline of three new 'Anti-Infective' programs, one of which was in 'Antivirals'. Investigation of the application of the Ureka peptide technologies within this Antivirals program suggests the potential to create effective anti-fusion peptides with the goal to prevent virus entry into the host cells, which may lead to novel peptide based antiviral therapies.
So lots to look forward to!