Member Info for DugWalker

I think Prostate Cancer UK understand the test and validation requirements. You can read their thoughts on the matter here.

Https://prostatecanceruk.org/about-us/news-and-views/2023/02/can-this-new-blood-test-diagnose-prostate-cancer-with-94-accuracy

Full clinical validation is still required via a community randomised trisl and that's why we need to be involved in the TRANSFORM project. I'm pleased to say I now have grounds to think we will be and will post relevant links tomorrow morning.

Cyberbub,

With respect to your thoughts on OBD & Transform. The link I'll post on Monday seems to suggest you are pretty much on the money.

I have managed to locate the actual call for proposals for Transform and it seems to actively encourage participation from companies like OBD, this fits with JimiHendrix's remarks that his communications with Prostate Cancer UK suggest they are quite enthusiastic about tests like PSE.

Furthermore there does not appear to be a defined deadline (short of the project budget expiring). So provided PSE is a fit for one of the proposed and accepted lines of research they should be able to join that branch of the project, even retrospectively.

Folks can read the call for proposals themselves, but yes I think some gentle pressure on the company might not go amiss, even though they may already be actively pursuing participation.

I'm not a medic but do have a scientific background and this is how I think of things here.

Validation isn't a yes/no issue it's more like a spectrum with a range of options. So the small sample size is fine to validate the test method. In that case we were looking for several distinctive dna biomarkers that serve as a fingerprint of prostate cancer. If it can be shown that men with the cancer have common features present in the dna fingerprint that are absent in men that don't, then it doesn't require a huge number of tests to validate the test concept. I think that is where we are at. We now need to move further along the spectrum and demonstrate that the PSE test works for all men from different ethnic backgrounds, different age groups, different family histories of prostate cancer etc etc. I think of that as full clinical validation. Obviously it needs many more tests to reach that target but we are starting from a solid foundation and since we are already using the same diagnostic concept for other cancers, we have grounds for confidence.

I may not have all the details correct but as a description of the 'big picture' I think the above is reasonable. Hope it helps.

Took some time to unravel the relationships and roles of Prostate Cancer UK, the National Institute of Health Research, the Dept of Heath and Social Care and the National Screening Committee but I got there in the end. In the process I unearthed some documentation relevant to the Transform Project and how it could provide a fast track opportunity for OBD to get wider validation of PSE. I have reverted to my original opinion that OBD will most probably be involved in the trial. You live and learn.

Will post links to the relevant documentation and information Monday. Sorry but ran out of time today.

Fair play NU.

Got some more encouraging news to share later.

So I'm here to hold my hands up and admit I have been labouring under a misconception.

A couple of days ago I posted an email I sent to the NSC asking for clarification of their blog announcing the Transform project and highlighting some ambiguities that seemed to arise with comments on the Prostate Cancer website. Here is their reply;

Dear xxxxxxx

Thank you for your email.

To clarify, the recent UK NSC blog article on prostate cancer screening had 2 main themes, which were to:

welcome news of the TRANSFORM research trial

explain the work the UK NSC will take forward in response to the 6 submissions it received during its annual call for topics

These are 2 very distinct and separate pieces of work. The UK NSC has no responsibility for the running of the TRANSFORM trial, so you would need to contact Prostate Cancer UK about your query regarding the wording on its website.

The annual call submissions we receive are not necessarily detailed formal research proposals. However, we do provide guidance on the type and level of information/evidence that people/organisations should include in submissions on our UK NSC annual call: submitting a screening proposal web page. The UK NSC is now commissioning an evidence review based on the 6 prostate screening submissions that it received under the annual call.

Kind regards,

The fact they conflated 2 separate initiatives under a single banner headline 'UK NSC welcomes major new prostate cancer screening research' led me to read all of the content as pertaining to the Transform Project. The comments about the 6 submissions made to NSC's annual call for proposals and the remarks from the NSC that they had worked with Prostate Cancer to design the Transform trial had me assuming that the blog was referencing a collaborative call for proposals relating to the Transform Project and it was this that informed my decision to sell some of my holding. With benefit of the NSC clarification that they have no involvement iin the running of the Transform project means my interpretation of the blog was wrong.

Completely agree GMS. The notion that a single PI with a substantially lower than TR1 level of holding can materially impact a share price by posting on a forum seems absurd to me regardless of the direction of travel of the SP.

Ho hum....

@ Nothopeful.

In fairness, when I posted that I had reduced my holding I provided a link to the NSC blog that prompted my action and explained my concerns. To me the facts had changed indeed I had previously expressed confidence that OBD would be involved in the trial but the NSC blog cast doubt on that for me. I did as you quite rightly suggest, provide all the info needed nor others to make their own judgement (a link to the blog).

I agree the exchanges are becoming infantile and have as you can see, suggested that NU a d Dib's stop reading and responding to my posts. For my part I will no longer post my research that I consider relevant. Should hopefully solve the problem.

NU.

I don't need your advice on my investments and frankly couldn't give a t0ss if you are upset by my responses. Your options are to stop your playground tit for tat by not responding and if you choose simply stop reading my research (both positive and negative) which I have been posting in here so others are aware and can decide for themselves if it is important or not.

Dib's the fact that you believe nothing has changed demonstrates a lack of comprehension which you amply demonstrated with your assertion that I was posing as a medical professional.

I strongly suggest you and NU spend your time more productively by writing to the company to highlight the benefits of their participation in the UK screening trial. The pending review of CLIA regulations is a very good reason for doing so.

So you now accept we are targeting the UK market. That's progress.

NewUncle.

That does not preclude the possibility that OBD would like to target its home market too.

Https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests

The link below doesn't work. Hopefully this one will.

If not Google 'FDA proposed rule laboratory developed tests'.

Good post Jimi.

There is an ambiguity between what Prostate Cancer UK seem to be suggesting and my reading of the NSC blog posted a couple of days ago that led to me reducing my shareholding. I am trying to get clarity and have sent the following email to the NSC.

--------

Having read your blog and the announcement of TRANSFORM on the Prostate Cancer UK site I am confused by how the final study is to be defined. For example, I note that the blog describes the 6 'submissions' that have been made in response to a call for proposals. Could you please clarify if these submissions constitute formal research proposals with defined resource requirements, participants, objectives and work programmes or are they simply suggested research themes/topics?

A call for proposals would suggest the former, but my confusion arises from the following comment from the prostate cancer uk website,

"We will confirm details of the research itself, including what tests are being trialled and how men can join the trial, once contracts have been finalised in Spring 2024".

This seems to suggest that the participants, work programmes techniques and methodologies are yet to be finalised? Can you please clarify this apparent ambiguity?

------

In the meantime I note certain posters accusing me of 'spin', misrepresenting myself as a medical professional, and deramping. I find such ad hominem responses to be nothing short of comical. Agree with me or not I have, as other posters have noted, been completely transparent and have stated my reasons for reducing my holding. I have at all times been consistent in my view that the PSE test is a potential game changer and I also continue to believe that if OBD are not involved in the NSC trial that it will be very damaging to it's roll out both in the UK and the US.

The fact that Stockholm3 is still regarded as unvalidated following 75,000 applications to Scandanavian patients is indicative of the numbers of tests required to satisfy the medical community of adequate representation of all ethnic groups, ages and genetic groupings. This is the major benefit of OBD participation in a national Cluster Randomised Trial. It provides immediate access to hundreds of thousands of patients many of whom will be asymptomatic. That will not happen if dependent on tests conducted on patients with symptoms which is what you get from private sales to individual doctors or patients.

Finally I hear comments that the UK is not core to OBD's strategy. I find that difficult to reconcile with the ongoing lab upgrades and the placing of last year. I suspect OBD are at least aware that approval of this type of lab based test is under review by the FDA in the U.S. it seems increasingly likely that they will soon revoke the CLIA accreditation route. Trials such as those about to take place in the UK may soon be required in the US eliminating the fast-track to market option.

Https://www.fda.gov/medical-devices/in-vitro-diagnostics

NU where were your complaints when I was one of the strongest advocates of the share for several .months?

I'll continue commenting as I see fit and when facts change I'll change my opinions.

I've consigned you to the same category as Dibs, a man who clearly thinks a highly educated medical professional uses 'us oncologists' as a collective.

Dibs .

Show me where I claimed to be a medic and provide a full quote not something lifted out of context to include the term us oncologist when it was obviously intended to read U.S. oncologists.

You are coming across as Laughably infantile.

Morning GMS ,

That's a completely logical and sensible overview with respect to revenues, P&L and how they might change short term. Completely agree. However this is an AIM share and in AIM sentiment can be as big a factor, sometimes bigger, than corporate accounts.

An example, I am also in PXEN. A small gas producer in Italy and Spain, it was last years blue riband winner in AIM as the SP rocketed from low single figures to almost 20p. Many mid to long term holders bagged 7 to 10 times. Then a TR1, who had been ramping the share bailed and took sentiment with him. PXEN has since gone from loss making to bringing in what will be about £6million profit year as their first well started producing several months ago. The SP is still languishing in the 5's. Sentiment counts for a lot in AIM.

In the case of OBD the recent sharp rise in SP was mainly a result of positive sentiment arising from the launch of PSE. That brought in a lot of new investors. There has to be doubt that they will all stick around if OBD is not in the screening trial. That's a concern to me.

Anyway I have emailed the NSC seeking clarification of their proposal process and the Prostate Cancer UK announcement of TRANSFORM. I'm hoping their response will shed light on whether or not OBD might end up as participants.

Will keep the forum informed as and when...

Glad to hear that Jimi.

I had a PSA and digit up.the Jacksy earlier this year. All went well until I remarked to the doc that I hoped there were no.plans to take advantage of me 😄

@HG44. Many thanks. Always good to keep an open mind to information be it good bad or indifferent.

@Jimi. Thank you too. If you are volunteering for the trial out of a sense of social responsibility well done and thanks. I hope it's not because you are having prostate issues, but if so I would talk to your GP ASAP as I believe recruitment will be done by GP's. Also I hope you benefit from Transform in all the best possible ways.