Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
The UK Health Secretary has just announced plans to streamline the drug approval process in the UK and I post an excerpt below, with apologies, as it is behind a pay wall, so will not copy and paste with a link:
"Life-saving drug trials will get the green light more quickly under plans to take advantage of Brexit by cutting red tape.
Steve Barclay, the Health Secretary, will on Sunday announce a new fast-track process halving the time it takes for some research to get under way.
Regulators have cleared a backlog of more than 2,000 applications, which built up after a surge of interest in research in the aftermath of the pandemic.
Writing jointly with June Raine, the head of the Medicines and Healthcare products Regulatory Agency (MHRA), Mr Barclay pledged to streamline research processes further as part of the biggest reform of clinical trials for more than 20 years.
The changes have come about because regulators have more freedom to design their own processes, including identifying trials that can be authorised more quickly.
Although applications should be assessed within 30 days, the average wait hit four months earlier this year following a surge of applications. In an average year, the MHRA normally approves around 750 new trials per year. Since July, it has approved 2,200, wiping out a backlog of almost 1,000.
Steve Barclay has pledged to streamline research processes further
Steve Barclay has pledged to streamline research processes further CREDIT: Paul Grover for the Telegraph
On Sunday, Mr Barclay and Ms Raine will set out plans meaning that approval time for low-risk trials will be reduced to 14 days. The changes apply to phase three and four trials, meaning safety risks have already been examined, and in cases where there are no known safety risks."
Bear with me because much of this is above my pay grade but given that XF-73 has an excellent safety profile and accordingly we were able to undertake a phase 2b trial aimed primarily on the efficacy of the treatment, which was passed with flying colours, I wonder if this new development would be of benefit to our phase 3 trial of XF-73.
I hesitate because the trials to date have been regulated by the FDA and I do not know if it's possible, if desirable, to run an alternative trial in parallel under the direction of the MHRA ?
The design of the phase 3 trial has already been approved by the FDA :
https://www.investegate.co.uk/announcement/rns/destiny-pharma--dest/xf-73-nasal-final-phase-3-development-plans/7321095
The phase 2b trial, once recruited, took 3 months for results, with a patient sample of 125. The increased cohort in phase 3 will clearly lengthen the time of the trial but we look to be an excellent fit for these new plans announced today.
I'd be interested in people's views.
Thanks for the clarification, which I believe was necessary as the two companies are operating in completely different fields of medicine.
OBD mainly operating in the area of screening tests for an assortment of conditions, evolving from their 3D genomics expertise.
However, I do note the recent success of their PSE prostate cancer test showing a 94% accuracy against 55% for the standard PSA test and OBD's over 4 fold share price increase on the release of this news, together with the launch of the test.
Thus, it's worth emphasising that XF-73's performance against the current standard of care in our market (Mupirocin) is even more impressive than the figures above, as detailed in the Company's recent Investor meets presentation.
Captain james t kirk2 Nov '23 - 07:29 - 1977 of 1977 Edit
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For those folk not aware, GSK were the first to market Mupirocin, the current standard of care to prevent post surgery infections.
Mupirocin needs to be dosed 5 days pre op, against one day for XF-73. It does not eradicate all strains of microbials, whereas XF-73 does and microbials build resistance to Mupirocin. There is no microbial resistance to XF-73.
XF-73 is effective against biofilms. Mupirocin is not effective against biofilms and is an irritant, whereas XF-73 is non irritant.
I'd be surprised if GSK wasn't interested in XF-73.
Destiny signed an agreement with Sebela to take NTCD-M3 to phase 3 trial :
https://www.investegate.co.uk/announcement/rns/destiny-pharma--dest/agreement-with-sebela-pharmaceutical-for-ntcd-m3/7235249
and Chris Tovey, the recently acquired CEO, is on the case re XF-73 and the rest of the pipeline:
https://www.investegate.co.uk/announcement/rns/destiny-pharma--dest/board-changes-including-appointment-of-new-ceo/7642442
I agree with all that you say and as you no doubt realise I was fishing to find out if someone can flag a potential red flag.
Apart from the delay in progressing to phase 3 trials the facts do appear to speak for themselves.
That said we mustn't lose sight of the macro events that have taken place since 2020.
I've just re watched some of the presentation, notably the Bill Love section, the Prof Proctor bit and the closing, including the questions.
I suppose in comparison to some on here, I'm a little late to the party, buying in on the Chis Tovey and Sir Nigel Rudd appointments, plus a little research of course :)
Following on from the Investor Meets presentation and digging a little deeper, this does appear to be too good to be true and one is bound to ask what exactly is the market missing or is it more the case of what am I missing. The facts thus far for the performance of XF-73 do point to a blockbuster in the making.
I know there is currently almost unprecedented market malaise but even so, when one looks at past valuations of companies in the sector with a fraction of the potential of Destiny and its XF platform, the current valuation looks absurd.
Perhaps prior to the appointment of the above named individuals Destiny was strong on the science but not so good on the commercialisation side of the business. That's certainly as I see things, particularly with the appointment of (I've got the t-shirt) Chris Tovey.
Incidentally, whilst digging I came up with this article, which just before the Prof Proctor comment mentions the FDA fast tracking XF-73 , which will be of interest to Buena.
https://markets.ft.com/data/announce/full?dockey=1323-14916402-2O2OG8D0MQOBEATVANT1GHNG77
Buena
This is probably the most relevant rns re the FDA and EMA and progress with the same.
Chris Tovey has been brought in to bring this to fruition , along with progressing the rest of the pipeline:
https://www.investegate.co.uk/announcement/rns/destiny-pharma--dest/xf-73-nasal-final-phase-3-development-plans/7321095
It's all part of the published strategy:
"XF-73 nasal programme
In line with our stated strategy, we are actively seeking partners to complete final clinical development and commercialisation of XF-73 nasal. Good progress has been made during the period and we are already in discussions with multiple interested global parties. We expect to make further progress during the second half of the year with the intention of securing the best possible deal and partner to maximise the significant market potential for XF-73 nasal."
I don't know if this will work but it should put you on the right path.
https://presentations.investormeetcompany.com/conferences/2c34956364b4/bigroom
One does get the impression that the analyst/investor presentation was timed to coincide with this news, which they would have known was imminent.
Telling that the meeting is timed for start of play of our friends across the pond.
Only had time for a quick skirt around:
hTTps://www.datanyze.com/companies/caltech-trading/355852590