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Good post re: 501k summary, thanks. I agree, pi panic, nervous ahead of the update...

In RNS: A further update on the agreed process with the FDA and the likely new timelines for approval of the 510k will be made in due course.

It'll come. Possibly holding off on half year update so they include more detail on what is obviously an ongoing moving situation

Were 11 Dec last year I should clarify!

And any II buys like Dowgate will be interesting

Half year results were 11 Dec, so due soon. If they're positive in outlook, with well articulated strategy and financial runway, we should bounce when we're all the wiser.

Well it wings for the sleepiest c-19 stock on AIM... How long will it rest before it wakes up with a bang? Surely positive drivers here... I'll hold, top up and wait.

This is a disappointing drop. My top up yesterday at 107 was premature and too eager. Easy in hindsight.

Wonder what's pulling this further down - are investors questioning if this has further ramifications?

It's a long-term play for me, but was hoping for positive trading momentum from the RUA Medical unit. Interested in others' thoughts

Wonder how Elliott will play it? They were buying in the low 600p through summer and saw value presumably in a break up of products and services. I'd speculate they'd want a better return than ~20%. As would I.

LIBERUM CUTS CLINIGEN PRICE TARGET TO 780 (800) PENCE - 'BUY'

Are people starting to focus on services now today's news is out there? I'm confident here and mindful of this statement from the results...

"The outlook for Services is positive with a continued strong pipeline and a good number of new high value projects to deliver revenues in FY2022. There are currently more than 350 opportunities across the pipeline with a combined value of more than £80m"

Rather misleading RNS headline!

Agree patience is key and also that cash position should have risen substantially.

Cellular pathology and genetic sequencing a huge opportunities in the future and if the current COVID testing windfall allowed them to acquire business in those areas it paints a rosy picture both short and long-term.

PCR testing back for travel and we have the best value day 2 test on the market according to Which?

£110m MC, below IPO. But with sales growing to approx. £85m this year from £50m. With a growing cash war chest, last noted at £17m.

So..... Am I missing something obvious?

Why is this so under the radar/unloved?

From the boss in the interims:
"We expect the focus of acquisitions to be similar or complementary businesses most likely relevant to the Healthcare Diagnostics (with cellular pathology and precision medicine targets being of particular interest) and Genomics business units."

SBI will use the testing profits to push the business on.

https://news.sky.com/story/activist-elliott-floats-break-up-of-pharma-services-group-clinigen-12404003

EARLY STAGE ASSET DEVELOPMENT (ESAD)
? INDV-2000 (Selective Orexin 1 [OX1] receptor antagonist):
- Phase 1 Single Ascending Dose (SAD) study has completed and shows encouraging safety and pharmacokinetics in
healthy volunteers. The final Clinical Study Report is expected by the end of Q4-2021.
- The Phase 1 Multiple Ascending Dose (MAD) study is currently planned with the first subject anticipated to be dosed
in Q3-2021.

357p... GLA

https://twitter.com/equity_research/status/1376423311773696004?s=19

Will it rise over £1 when RNS follows?

Here's what they've previously stated...

"In parallel with the regulatory discussions, the Company is assessing the opportunity to fund the US Phase 3 development itself in order to increase the future value of the programme, as well as significantly broadening the pool of potential commercialisation partners."

Promising.

As confidence builds for European approval worth reminding ourselves of the outlook statement in the Feb interims...

Outlook



If approved by the EMA, Chronocort® will provide the Company's commercial cortisol replacement therapy franchise with critical mass, enabling Diurnal to build a strong and profitable European business through penetration of the combined addressable market for the treatment of CAH and paediatric AI, which is estimated by the Company to be worth c.$300 million in Europe alone. In addition, the Group expects an increased contribution from its licensing and distribution partners outside of Europe once regulatory and/or pricing and reimbursement activities for Alkindi® are completed in these territories.



In the US, Diurnal continues to assess the optimal timing for seeking a partner for the commercialisation of Chronocort, which may be following the completion of Phase 3 development itself: if successful, this would be expected to markedly increase the value of the asset.



DITEST™ represents a further valuable addition to Diurnal's growing pipeline of novel endocrinology treatments and, following the fundraising in October 2020, the Company will move forward with the next stage of development in order to maximise the value of this product in the $4.8bn potential market in the US and Europe.

Thanks to those who indulged my question, some really interesting food for thought. Appreciate the replies. SNG is 15% of my portfolio now so want to assess it more than on the first spike.

Really think its true strength would come through in exacerbated patients prior to hospitalisation, which the at home trial well hopefully prove it eventually.

Even if, and don't mean to be glass half empty, the P3 didn't wow, it'd no doubt open up a huge to up opportunity for the longer game: saving lives of COPD patients from myriad viral infections.

Presumably if it was 85% share prices would rise substantially higher off the back of phase two results.