The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
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Thanks Tommy, great find.
With my very limited understanding it seems that an orr of above 30% is required for funding and approval and val has 54% which must be very positive surely.
With Keytruda ORR of 24% https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5574183/
Maths prof - thanks for sharing the statistical analysis. Indeed why this has fallen today has nothing to do with sample size.
Even on the worst case it’s not dissimilar to the cancer drugs already Marketed which work in 30% of cases
Thanks Grace and l think the podcast on BRR will be nerve calming.
In fact with BRR, Hargreaves increasing his holding and the SP consolidating today, l can’t see any reason for the SP will not to go back in to the 30’s tomorrow.
no worries .. i had not read that ..
leave you with it ... seems the market will have to fund it anyway .. so lets see what that entails
inanaco - an extract of one of my posts from yesterday:
"Results confirm that the last 3 years extension of the trial has largely been a waste of time.
It has achieved (presumably similar) results to the earlier ones, with the extra information that the 8mg dose is safe (but no RNS info on the 16mg dose yet)."
The difference from 3 years ago lies in the re-invention of the company which may lead to a properly funded PII trial now. That's why I think the company is worth a lot more than 3 years ago.
Yes, yes, yes! This right here! (Ignoring inanaco and his disingenuous comments, as I know he knows better than what he’s posting...but I can’t be bothered to argue the toss today)
This is what I’ve been saying all along! Bad trial design...remove the lower doses and the castration sensitive and then see what we have in the full results. That’s what I will be looking out for and that’s also what will be important in companies viewing our results and making decisions on them.
The only niggle I had yesterday about the wording of maximum dose was cleared up by Suzy today. I knew there would have been a reason for not going higher, as the drug clearly works, so didn’t understand why the headline results mentioned it so much. Turns out there was a perfectly reasonable explanation and it was only included purely for the purposes of transparency by Suzy.
I liked the results
Apart from most of them knock you out like a sack of spuds; this one looks to be positively homeopathic in it's side-effects.
mathsproof if you read the 2017 RNS .......... its exactly the same position as of today
London, UK., 18 December 2017: ValiRx Plc (AIM: VAL), the clinical stage biotechnology company, is pleased to announce that the Company has received approval from the MHRA and REC for the Company to expand its VAL201 trial for the Phase I/II Dose Escalation Study in Patients with Locally Advanced or Metastatic Prostate Cancer and other Advanced Solid Tumours.
VAL201 has demonstrated consistently high safety and tolerability, as well as preliminary effectiveness throughout the clinical study. Following the successful completion of this stage one of clinical development, with no serious drug related adverse events noted, the MHRA and REC have accepted the Company and clinical team's request for this escalation to the study. This approval allows for a substantial increase in the dose of VAL201 being administered to patients, thereby allowing treatment to more speedily reach its full therapeutic potential and potential anti-cancer impact. Further analysis will be provided in due course following a more comprehensive evaluation of the data.
This regulatory approval permits ValiRx to;
· To substantially raise the dosing level in patients in order to reach therapeutic levels and reduce disease progression;
· To assess at what stage in disease development the compound can be most effectively deployed in subsequent, larger, outcome-oriented clinical trials; and
· To determine which route and with whom to take the project to its next stage - by the Company or with a partner.
Bang on; then take the disease heterogeneity and lower doses out MathsProf (when the data arrives).
Mathsprof ... that would be fine if this area was an unmet clinical need ....... but it is not ..
so the statistics including the safety etc needs to include a comparative ... of efficacy
VAL have reported a 54.5% success rate on a sample size of 11. Small sample we say. But how much does this matter?
The smallness of the sample can lead to non-significant results and therefore are not much use. A larger sample is always more robust.
In this case, using a simple Binomial model, I have calculated a range of values we can expect from our observation of 6 out of 11 "successes". There is a 95% probabilty that the actual success rate could be anywhere between 25% and 86% . This to me is very encouraging, because, even on our sample of 11 it is likely that a quarter of all patients would respond positively to the treatment, and it may be substanially more.
I look forward to the fuller data analysis, and further progress with 201, 301 and BC201.
P.S. I've added a few more today too.