Ryan Mee, CEO of Fulcrum Metals, reviews FY23 and progress on the Gold Tailings Hub in Canada. Watch the video here.
Grace83 ...
let me explain ... why i point out what i consider "deficits" in the information given out by VAL and look at the efficacy data and what a particular Trial involves
The Original Trial protocols Changed, now if efficacy had been achieved at the lowest dose right up to 8mg that was sufficient to generate the data required to carry 201 into a Major phase 3 trial we would not be having this conversation now. The reason for that, the Phase 3 control Arm will include current standard of care, in other words a Head To Head study, For sure you stand a great chance in the toxicity department to beat standard of care and you could certainly take some market share even if efficacy is lower.
But ..
Val has not completed its dosing schedule to formalize that trial and may consider a further increase in dosage as per the 16mg permission
And that is the issue ........ if the efficacy is good enough why do you still need to run further trials just to sort that out in small numbers before you enter into a full efficacy trial at phase 2 ..
which then asks another question ....
why does VAL not run this small trial and fund with shareholder funds ........ as everybody in the business knows . Data is Valuable .. and at the End of efficacy studies ..... not the beginning, so what is stopping Val running that trial ? This is exactly what the stock market is for ..
not ramp or deramp SP is not relevant
Didn't take long did it .......... out comes "disappointed" ..... after his U turn to buy from his previous position one would expect at least 6 months of positive mindset ..
For the Record Scancell does have a lot on the Go ... most of which we already know about
they approved the uplift to 8mg ....... Val would have needed to show safety to get the next uplift to 16mg ....
No RNS to say that was refused ...........
another question that i cannot answer
MHRA and REC approve a major update to the trial of VAL201 including the appointment of a Principle Investigator to the clinical team
Following approval of the substantial amendment, an authoritative prostate cancer specialist, Dr Mark Linch has been appointed as Principal Investigator to the clinical trial team at University College London Hospital ("UCLH"). Dr Linch is an Honorary Senior Lecturer at University College London (UCL) Cancer Institute, where he leads the Uro-oncology Biology Group, and he is also a Consultant Medical Oncologist specialising in the treatment of prostate and bladder cancer at UCLH. Dr Rebecca Kristeleit continues with the study as Chief Investigator.
Normally they comment ............ why no comment ?
the point that i am trying to make is the Authority gave approval for the increase to 16mg ... VAL RNS that ... they did not subsequently retract that ... ie Remove the 16mg authority which they would have done if the dosage at 8mg gave indicators that would have. That would then require an RNS with an explanation. The Authority already agreed various changes to how they give the drug from the agreed protocols
so really this is very confusing ...
ValiRx have established that VAL201 is safe and well tolerated at doses of up to 4mg/kg and the Company can report that it has seen primary evidence of the drug's activity in prostate cancer.
Based on these results, the MHRA approved an extension to the trial (announced 18/12/17), allowing for an intra-patient dose escalation of up to 16mg/kg. This segment of the trial is in the concluding stages of its Phase l/ll (announced 17/10/18) and is progressing with patients to establish the maximum tolerated acute dose in Humans (MTD). This part of the study is also further establishing potential efficacy levels and pharmacokinetic / pharmacodynamic profiles as well, providing supporting information with respect to the optimal therapeutic regimes to be tested in the subsequent late stage clinical trials.
another passage from earlier RNS
To date, the results generated by the trial, aided by sizable analytical methods developments, have shown that safe toxicological limits can be significantly elevated and applied to much higher levels in humans, than was suggested by the pre-clinical studies. The approval given to relax the restrictions previously applied to the trial, mean that a more effective use of VAL201 can be achieved, with respect to concentration and timing and regarding increased flexibility in the administration of the drug.
well this does seem to conflict with earlier RNS ref Q and A
Patients in the clinical trial were dosed successfully at 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4 mg/kg and 8
mg/kg. At 8 mg/kg, the drug was sufficiently well tolerated for patients to remain at this dose, however
when the levels of VAL201 in blood were measured, they were found to be higher than the levels in rat
blood at the highest dose tested in preclinical testing (100 mg/kg). Therefore, due to the restrictions stated in the trial protocol, the dose could not be increased further
even though 8 mg/kg was tolerated. As a consequence, a maximum tolerated dose (MTD) cannot be
declared with the data we have. A Maximum Applicable Dose, that is a maximum dose that is required
for effectiveness in treatment of the disease will be determined in future trials.
which stated they had approval to dose at 16mg/kg
TF ... not bothered what you do .... you seem to use "filter" as a weapon like Ruck and Ivy ...But how on earth does that affect me .. the only loser would be you ...
"until there's some science for you to help with"
its like i said ... we had 3 months of "UK has it wrong ref Covid" from your Posts ...
with me telling you over and over .......... you will not stop the virus ..
who is correct ?
Now you are telling us Big Pharma are greedy ... and you """I don't feel CV-19 vaccine should be over priced either"""
UK has "NICE" exactly for this role, so why do you need to even question what is Over or under priced .. ?? you do not have access to the detail they do ...
Balanced Posting .. Opinion is fine .. but if you do ... Don't be surprised that somebody won't ask questions of You and your understanding of what you are posting .... that's balance
Influenza virus antagonism of innate immunity
The seminal study by Isaacs and Lindenmann [31] revealed that treatment of choriontic membranes with heat-inactivated influenza virus stimulates the release of an inhibitory substance (IFN) that limits the replication of infectious influenza viruses. In hindsight, these studies also indicated that, unlike heat-inactivated virus, infectious influenza viruses do not efficiently stimulate IFN production. More recent in vitro studies using immortalized human lung cell lines have confirmed that, in general, wild-type influenza A viruses are poor inducers of type I IFN [74]. Several further studies have uncovered the many strategies employed by influenza viruses to limit both directly and indirectly the global cellular antiviral state. As outlined below, this is thought to primarily involve viral targeting of the IFN-induction and signaling cascades at multiple levels. Influenza viruses are by no means unique in their ability to limit the IFN response, and in order to replicate efficiently all viruses must be able to counteract these host defences to some extent. How other viruses subvert innate immunity has been reviewed elsewhere [13,55,64].
this evasion is not knew other Virus like the Flu has this built in property to evade the primary immune response from lung infected cells
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2820251/
What is concerning me is the results from SNG trials . that Cells are being infected yet the immune systems first line of defense is compromised ... would a vaccine based only on Antibodies recognize this threat, i don't think it will .. antibodies cannot look at infected cells, it can only neutralize the virus in the blood stream .. meanwhile you are still shedding virus and infecting others .
Only T cells can take on viral infected cells ........
fascinating how this will all develop ..........
But i would again advise caution on the antibody response in the aged population. The flu vaccine is only partially effective despite years of development .. you can still die from the flu despite inoculation
Moderna is already testing the higher dose in a large Phase III trial, the final stage before seeking emergency authorization or approval.
Side effects, which included headache, fatigue, body aches, chills and injection site pain, were deemed mainly mild to moderate.
In at least two cases, however, volunteers had severe reactions.
One developed a grade three fever, which is classified as 102.2 degrees Fahrenheit (39°C) or above, after receiving the lower vaccine dose. Another developed fatigue so severe it temporarily prevented daily activities, Anderson said.
Typically, side effects occurred soon after receiving the vaccine and resolved quickly, he said.
"This is similar to what a lot of older adults are going to experience with the high dose influenza vaccine," Anderson said. "They might feel off or have a fever."
hardly ... only replied to your posts ....
Scancell has already indicated it wants to be as big as BioNtech ... who by the way is Not run on a not for profit basis .. or has a slogan .. "we only make 20%"
This is the capital markets ........
Money gets invested in projects that hopefully generate Profits ........ if you think that is Vulgar then why are you here ?
Why are you here .........
""Scancell LTH - doesn't have to be the usual Pharma rip off""
without Big Pharma getting involved we will not deliver a phase 3 product ........ and certainly not expand the portfolio or deliver it in any sort of realistic time scale ...
so yet again you seem to Project the Moral high ground ....... its not Good !!
even CRUK works for a "profit" so that it can take high risk development programs
so it licenses out it discoveries and receives royalties if they come good
The Government funded programs would receive Tax revenue as a result .... if the Government demanded not for profit the cost to the taxpayer is far higher than if it didn't ....
There has to be an element of competition ... otherwise you will not get the best products .. all this left wing dogma that the Hippies come out with only achieves a state that is going backwards ... Cuba is a prime example
The Oxford Academics by the way don't work for nothing ........ They are Highly paid !!