Gordon Stein, CFO of CleanTech Lithium, explains why CTL acquired the 23 Laguna Verde licenses. Watch the video here.
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From SNG website......
" This is a pilot trial requested by regulators to validate the additional questions that are included in SG018 which determine the OSCI score when patients have been discharged from hospital. The study is proceeding on time and as it is an independent study, will not delay the SPRINTER study (SG018)."
I had steak and chips for tea 3 months ago today.. I didn't have pudding or cake.
Can you remember what you had for tea 3 months ago today ? I doubt it so why would someone remember how they felt 3 months ago today. What a thick question.
Good luck to you too. I’m only holding on three, this is my Tokyo but I’ve appreciated you elsewhere. This looks like something special, let’s hope it delivers for everyone.
Hi Hop2,
Always been here just the holding that varies. Lol!
It’s nice having a stock where one doesn’t have to worry no matter what the outcome. Hoping for a nice 10k share top slide at £10 at some point this year though!
Good luck with your investments
Trek
Welcome back Trek. I know you have been missed. Hope it finds you well?!
Fed minutes are out. Not sure on link as I read on CNBC app. They basically underlined changes and amendments in red.
To summarise there is concern still around progress of virus, vaccination uptake and future mutations. It’s a different tone to UK plc’s narrative. Well IMO as a ‘temperature check’ it certainly aligns with or the mood doesn’t rule out stockpiling should an opportunity manifest.
“ The Federal Reserve is committed te using its full range of teels
to support the U.S. economy in this challengine time, thereby
promoting its maximum employment and price stability goals.
With progress on vaccinations and strong policy support,
hAdicatorsIndicators of economic activity and employment have
continued to strengthen. The sectors most adversely affected by
the pandemic have improved in recent months but continue to
beare being affected by the recent sharp rise in COVID-19 cases.
Job gains have been solid in recent months, and the
unemployment rate has declined substantially. Supply and
demand imbalances related to the pandemic and the reopening of
the economy have continued to contribute to elevated levels of
inflation. Overall financial conditions remain accommodative, in
part reflecting policy measures to support the economy and the
flow of credit to U.S. households and businesses.
The path of the economy continues to depend on the course of
the virus. Progress on vaccinations and an easing of supply
constraints are expected to support continued gains in economic
activity and employment as well as a reduction in inflation. Risks
to the economic outlook remain, including from new variants of
the virus.”
“ https://fm.cnbc.com/applications/cnbc.com/resources/editorialfiles/2022/01/26/Fed_statement_comparison_Jan_2022.pdf‘
Usual caveats
Trek
The study (NCT05207293) will be used by the FDA to determine whether clinical outcome assessment is as intended when used during clinical trials and will support approval and labelling. It's for the EUA application, the pilot test interviews refers to something else.
Thanks for posting. All these questionaires look at different areas of health utility. Some of them are fairly broad and can be applied in different conditions. Others are a bit more precise.
It is becoming more common to include these in studies because of the demands to secure reimbursement. If Sng can demonstrate a longer impact on health cf. Non treated patients then they can justify a higher price. They can also bench mark against other products or conditions using same questionnaires. The development of a new covid specific questionnaire s nuances against the broader less sensitive tests time be examined.
Positive that SNG are driving in this direction - shows they are thinking ahead and possibly cogniscent of likely outcome (I made that last but up)
Thanks for the link.
I still think if we selected 25 candidates at random from our own trial and interviewed them in such detail it would have been more representative of the accuracy of the results.
This looks like a new request from authorities or an ommission from our original tial.
Shah
https://www.fda.gov/media/131230/download#page9
This may help you
Pilot test interview guide (i.e., administer the interview in a small number or participants to identify and correct any methodological or logistical issues before using in the qualitative study).
@Winit, it's standard practice to submit a study of this kind for NDA or EUA, the number of patients varies (doesn't have to be 25). Just shows that SNG are gearing up for submitting EUA.
Skippy, I ain't sure at all but I don't think it is an external audit, Synairgen are the sponsor for the " pilot study"
As has been suggested, let's hope it's to provide further underpinning to fantastic results.
Enjoying the chat but I have to go to 5-a-side footy now...if my old bones will hold up !!!
Forgive my misunderstanding, but is this pilot anything to do with Active 2, phase 3. Because to my knowledge I don't think anyone has noticed a first patient dose confirmation or recruitment complete etc, so why do a 25 person pilot of this kind? Can't quite square the circle. Can someone educate me please?
Maybe they have seen the trial results and the authorities feel the results are too good to be true so just checking by interviewing 25 people to make sure they understood the questions when they were saying we are 'perfectly fine after taking SNG' ;)
To me looks like external audit of part of P3 trial approach on back of USA medical authority being asked to admit the P3 data for USA approval purposes.
Hi Marik, if it is standard practice to use 25 participants in such a study for NDA or EUA then that sounds positive.
Still wondering why it is referred to as a "pilot study".....what's next?
SHA222, I think it's irrelevant if the 25 participants took other types of medications. I interpret it to be about whether ANY patient (on the SNG018 trial or not) can consistently interpret and respond to the questions used to measure patient improvement.
It's about confirming validity of data recorded.
"Why interview 25 new participants..."
It's standard practice prior to NDA or EUA.
Why interview 25 new participants for up to 2 hours with a set of detailed questions with detailed scoring system to evaluate the validity of the 2 questions included in our SG018 trial? What would you gain from this?
It is not clear if these participants have had any other forms of medication which may skew the answers.
Why not revisit 25 SG018 participants and ask these questions for comparison?
The 25 participants (not previous SNG018 trial participantsl) are interviewed for 90-120 mins, so it seems it's about ensuring the participants could correctly understand and presumably consistently respond to the questions being asked. I interpret this as being intended to provide supportive evidence that the questions used (and responses/info gathered) can be relied upon as valid data.
I am curious as to why this is a "pilot study" it implies to me that further more detailed studies around this subject will also be conducted.
I don't really understand this fully but am making my interpretation. I would appreciate any thoughts as to why this is referred to as a "pilot study" ?
Don't want to sound negative but is there a potential some of the patient recorded data could be a "bit fuzzy" (one of NDN's past phrases think?). At the time this pilot trial was instigated, I would have thought there would be info (at least anecdotal) as to how patients were finding it easy to provide clear feedback or otherwise.
@Brand, I'm quite diversified and SNG represents a small portion of the portfolio, but non the less a very very interesting one as my average is low. So spent a lot of time reading and commenting on others.
Fair play mate. This is my only investment so spend a fair amount of time here...
"Yes it was well discussed at length by some of the most distinguished members of this board."
@Brand. That would explain it, I've been away from the board for a while and didn't get to see these discussions. The 25 person trial is good news as it's for the EUA.
WPA, it looked like it was 3 sites in the UK and 1 in the US.