Sapan Gai, CCO at Sovereign Metals, discusses their superior graphite test results. Watch the video here.
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Not a good one either
Not a bad day all round}
I recorded an adverse event whilst reading your post Burble.
Only joking :-)
So there are five main levels of adverse events when running clinical trials - Adverse Events (AEs), Adverse Reactions (ARs), Serious Adverse Events (SAEs), Suspected Serious Adverse Reactions (SSARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs)
AEs - are unfavourable and unintended signs, including abnormal results, symptoms or disease associated with treatment. These are recorded in case report forms and in the patient notes.
AEs can be classified as serious or non-serious, expected or unexpected, study related, possibly study related or not study related. Minor AEs are reported in bulk to the sponsor and generally are noted and submitted later but are reviewed at regular stages through a trial.
AEs are generally reported in grades
1 - Mild AE (asymptomatic or mild symptoms, no intervention required)
2 - Moderate AE (minimal, local or non-invasive intervention may be needed)
3 - Severe AE (not immediately life threatening, but medical intervention required)
4 - Life threatening/disabling AE (urgent intervention required)
5 - Death related to AE
Throughout a trial generally you will have a reasonable amount of Grade 1 and Grade 2 AEs, but these generally include things like 'patient experienced a headache after injection' or 'pain and reddening at site of injection'. Generally clinical trial results often report the number of Grade 3 or Grade 4 adverse events. Depending on the nature of these, a trial may be halted temporarily or stopped all together if severe enough.
ARs - are adverse events but casually related to the investigational product. So any untoward and unintended response in a subject to an investigational product.
SAEs - are any untoward medical occurrence that at any dose results in death, hospitalisation, prolongation of existing hospitalisation, persistent or significant disability/incapacity or a congenital anomaly or birth defect. These must be reported immediately to the sponsor. Example TGN1412 clinical trial.
SSARs - are any ARs considered consistent with information about the investigational product. These must be reviewed at regular intervals to see if the profile of the investigational medicinal product has changed.
SUSARs - are any events suspected to be caused by the trial drug, but which are not consistent with information about the product. (These are the most serious and are subjected to expedited reporting). An example of this was the SUSAR which occurred with the AZ Covid-19 vaccine resulting in temporary pause of the trial.
So when SCLP say no safety concerns - read this as none of the following:
- AEs - Grade 3, 4 or 5
- ARs
- SAEs
- SSARs
- SUSARs.
Hope that helps. It's quite a complex part of clinical trials and have many reporting lines with how quick things need reporting and to who. Hence for every clinical trial you have a clinical trials unit who deals on nearly a 24/7 basis with the appropriate reporting and actions.
An example would be something like Injection Site Inflammation and Soreness. Is it a side effect? Yes. Is it a safety concern? No. It is a common reaction when injecting someone.
To me, a safety concern would be something unexpected or something that could lead to long term harm to the person. But as I said in my original post, Burble would no doubt be able to advise.
Either way though - no safety concerns is very significant.
Konar surely side effects would fall under the safety concern umbrella.
Neither mentioned in the update so we should assume all is going as well as planned.
Thank you Ivy…
ATB
True - but at least while slower than expected, it's continuing anyway - thank goodness!
Konar,
Sorry you are quite right about SCIB1 first patient dosed.
The good thing about a senile fading memory is that regurgitated news seems fresh and exciting.
Plus I've forgotten how long I've been invested (I think it was last week) so can't get impatient.
@RW - "No safety concerns" is indeed positive and not to be overlooked. It is a major positive outcome of a phase 1 trial. But afaik "no safety concerns" isn't the same as "No side effects" which is what you seem to be implying. Burble may be able to clarify.
Hasiba,
Won’t make any further comment on here but well done on ARB.
The emphasis on 'only 16 patients dosed' should also take into account the vital and very encouraging words 'no safety concerns.' Not 'minimal' or 'minor' - none. That's good.
That's right Konar - Nov 19th I see...
I wonder why ProActive headlined on it now ? Never mind.
How is scib1 first patient dosed news?? It happened in November
True, it is exciting !
Though SCIB1 has been a hot topic of conversation for a very very long time. What, I wonder, constitutes impatient?
Hasiba,
Scancell is potentially worth exactly the same today as it was yesterday.
The reason for the drop is not bad news but news falling below the overinflated expectations of a few impatient investors.
It's a shame that people have picked on "only 16 patients dosed" bit and seem to have missed the "first patient dosed in SCIB1 trial". This is highly significant news. Presumably this didn't happen in the last few hours so suggests no major adverse reaction?
Thanks for the shares Hasiba :)
Looks weak and without licensing it’s products or achieving partnerships soon..I expect sp to decline further towards S2.
I said it repeatedly that sclp is too small to monetise its valuable products.it seems a struggling task for them to hit targets…
I will reconsider entering at lower sp..
Disappointing RNS..
On a day like this when the general market is buoyant and sclp is going into the opposite direction!
GL