Ja bevares, man kunne jo risikere altfor stor kurs oppgang hvis man hadde meldt dette tidligere i dag. 
Perfekt tidspunkt det for alle andre enn de som solgte i dag på stigningen som var 
Tjaa vet nå ikke, foretrekker børsmeldinger på morgenen før børsåpning, evnt når børsen er åpen, pleier å ha best effekt.
Auda
Ja det var det da! Kina har blitt et usikkerhetsmoment og hvor lenge tar det før nedklassifiseringen trer i kraft? 
Hahaha første gangen jeg er helt ute på flere år. Klart det kommer mld. Og mange visste om den tydeligvis.
Jaja var en fin tur fra 47 til 57…
Fantastic news! 
Nå gjelder det ikke å få høydeskrekk allerede på 62,- til uka. Det kan meget godt være flere gode nyheter i løypa. Gi det 2-3 uker til 
Bare å nyte helga og glede seg til videre oppgang på mandag 
Dette er meldinger med mer substans.
Aksjonærlisten etter neste uke vil forhåpentligvis gi noen mer positive tegn på at det blir oppfattet positivt.
Lesestoff for i kveld
Sammendrag
FDA’s Proposed Reclassification of Blue Light Cystoscopy Systems: What It Means for Photocure ASA (OSE: PHO)
Informational analysis — not investment advice. Current as of 14 August 2026.
TL;DR
On 14 August 2026 Photocure disclosed (Oslo Børs newsweb message 679896) that the FDA has published a proposed order in the Federal Register to reclassify the blue-light cystoscopy imaging systems (FDA product code OAY) from Class III (PMA) to Class II (510(k)/special controls), on FDA’s own initiative — a genuine strategic positive that attacks Photocure’s single biggest structural bottleneck (dependence on one PMA-holding scope vendor, Karl Storz), but with the P&L impact years out.
It is the DEVICE, not the DRUG, being reclassified. Cysview/Hexvix (hexaminolevulinate HCl) is a CDER-regulated drug under NDA 022555 and its approval status is entirely unaffected; the reclassification concerns the cystoscopic light-source systems (code OAY) regulated by CDRH.
This is fundamentally a razor/razorblade tailwind, not a competitive threat. Photocure sells the ~93%-gross-margin drug (the razorblade), not the scope (the razor), so more device vendors = more sites able to run BLC = more Cysview vials. The more important long-term structural risk to BLC volumes is urine biomarkers, not device competition — and Photocure has hedged by acquiring Vesica Health. (AOL)
Key Findings
The action, precisely. FDA is reclassifying product code OAY (“diagnostic endoscopic light source systems” — the blue-light-capable towers/light sources used with Cysview) from Class III to Class II under section 513(f)(3) of the FD&C Act, on FDA’s own initiative. The 14 August 2026 disclosure confirms FDA has now published the proposed order in the Federal Register following its review of scientific, clinical and post-market evidence — an escalation from Photocure’s 13 April 2026 disclosure, which stated only that, per its 13 April release, “FDA intends on issuing a proposed order to reclassify FDA Product Code OAY in the second half of 2026.”
Not a drug event. Cysview (NDA 022555; approved 2010; flexible-scope/surveillance indication added February 2018) is untouched. The original approval was a linked drug-device pair — Cysview (NDA) plus the Karl Storz Photodynamic Diagnostic D-Light C system (PMA P050027). Reclassifying the device does not alter the drug’s label or approval.
Why it matters. Class III/PMA is expensive and slow; every would-be scope maker faced a full PMA. Class II/510(k) lets new entrants clear via substantial equivalence to a predicate, dramatically lowering the barrier to selling BLC-capable equipment in the U.S. Karl Storz has been the de facto sole U.S. supplier, and its March 2023 decision to discontinue U.S. flexible BLC tower production created a real bottleneck.
Financial context. Photocure is profitable at the core and growing. Q2 2026 Hexvix/Cysview revenue was NOK 140.0m (+11% cc), adjusted EBITDA NOK 27.2m; 436 active U.S. accounts (+20% YoY); (ScanX) FY2026 guidance was raised to 8-11% product revenue growth. Core product gross margin is roughly 93%. On the Q2 2026 earnings call (29 July 2026), CEO Dan Schneider said: “Despite the accelerating growth of Cysview business, today, Photocure serves less than 10% of the addressable market, despite strong clinical evidence and demand for blue light cystoscopy.”
Competitive dynamic. More device vendors means more places Cysview can be sold — a tailwind for the drug franchise. The genuine long-term threat to BLC procedure volume is urine-biomarker surveillance (Cxbladder, Bladder EpiCheck, Xpert, Vesica’s AssureMDx), which could de-intensify surveillance cystoscopy.
Details
- The Regulatory Mechanics
Product code and current classification. The devices at issue carry FDA product code OAY. The archetype is the Karl Storz Photodynamic Diagnostic D-Light C (PDD) System, approved via PMA P050027 on 28 May 2010 as a Class III device (advisory committee: Gastroenterology/Urology). Per the Karl Storz Citizen Petition (FDA-2022-P-2644, filed 21 October 2022), all FDA-approved devices under code OAY as of October 2022 were serial modifications (PMA supplements S001–S011) of that single original D-Light C device. The Saphira/IMAGE1 S system is the current-generation successor.
The legal pathway. Under section 513(e)/513(f)(3) of the FD&C Act — administered as an administrative order process since the FDA Safety and Innovation Act of 2012 (FDASIA) replaced rulemaking — to move a device from Class III to Class II, FDA must find that general plus special controls provide reasonable assurance of safety and effectiveness. The procedural steps are: (i) publish a proposed order in the Federal Register with a summary of the valid scientific evidence and proposed special controls; (ii) allow a public comment period; (iii) FDA may convene a device classification panel; (iv) consider comments; (v) issue a final order.
The chronology (confirmed from primary sources):
21 Oct 2022: Karl Storz files Citizen Petition (FDA-2022-P-2644) seeking OAY reclassification Class III → II.
28 Mar 2026: Photocure discloses FDA’s response. The release states verbatim: “The U.S. Food and Drug Administration (FDA) has elected to maintain, for the time being, the current regulatory classification for OAY equipment… while reclassification was not granted at this time, [FDA outlined] the requirements necessary to move forward successfully.” FDA asked for additional clinical evidence and more robust special controls, but did NOT identify concerns with the underlying technology, and explicitly retained authority to reclassify on its own initiative. Photocure framed this as a “clear and actionable roadmap.” (Photocure)
13 Apr 2026: Photocure discloses FDA has communicated it plans to issue a proposed order to reclassify OAY on its own initiative per §513(f)(3), targeted for H2 2026. Published by Tolv Hillestad, 08:30 CEST; flagged as inside information under MAR. (PR Newswire)
14 Aug 2026 (message 679896): Photocure “welcomes FDA proposal to initiate the reclassification of blue light cystoscopy systems from Class III to Class II” — confirming FDA has published the proposed order in the Federal Register, initiated on FDA’s own initiative following review of scientific, clinical and post-market evidence. (Note: the exact Federal Register docket number and comment deadline for this specific order were not retrievable from public snippets at the time of writing and should be verified on regulations.gov.)
Special controls (what a Class II framework will likely require). FDA’s March 2026 feedback explicitly demanded “more robust, comprehensive special controls.” (Photocure) Based on analogous optical/imaging reclassifications (e.g., the 2026 reclassification of optical diagnostic devices for melanoma detection, (Federal Register) and the ultrasound cyclodestructive device final order effective June 2024), (Federal Register) special controls typically include: biocompatibility of patient-contacting components; electrical safety and electromagnetic compatibility; optical/photometric performance standards (spectral output, illumination); software verification/validation and cybersecurity; labeling specifying use with the specific fluorescent imaging agent (i.e., cross-labeling to Cysview/hexaminolevulinate); and potentially clinical or human-factors data expectations for 510(k) clearance. The precise special controls will be specified in the proposed order and refined via comments.
Realistic timeline. Comparable device reclassifications have taken 1.5-4 years from proposed to final order (e.g., the ultrasound cyclodestructive device: proposed Sept 2018, final effective June 2024; (Federal Register) melanoma optical diagnostics: proposed June 2022, final effective April 2026). (Federal Register) A realistic base case here is a final, effective order in 2027-2028, with a comment period (commonly 60-90 days) in late 2026. Photocure/Karl Storz management have indicated alternative regulatory pathways could allow additional equipment partners to enter “as early as 2027.”
Predicate dynamics once effective. Once a Class II classification regulation with special controls exists and a legally marketed predicate is identified (the incumbent Karl Storz OAY system, once down-classified, or the first new-classification device), subsequent entrants can file a 510(k) demonstrating substantial equivalence. A 510(k) typically clears in ~3-9 months versus multi-year PMA timelines — the core reason reclassification “lowers barriers.” Existing PMA holders would also see reduced burden: post-reclassification, device modifications go through the 510(k)/letter-to-file route rather than costly PMA supplements. - Photocure Business Context and Financials
Company profile. Photocure ASA (“The Bladder Cancer Company”), Oslo-headquartered, listed OSE: PHO (US OTC: PHCUF), founded 1993, ~100 employees, CEO Dan Schneider. Core product is hexaminolevulinate HCl, sold as Cysview in the U.S./Canada and Hexvix in Europe/rest-of-world. Two segments: Commercial Franchise (Hexvix/Cysview by geography plus partner/other sales) and Development Portfolio. (MarketScreener) Photocure sells directly in the U.S. and Europe (having bought back European rights from Ipsen in 2020), with partners including Asieris (China — Cevira and Hexvix), and distributors in Chile, Australia, New Zealand, Israel, South Africa.
Recent financials:
Q2 2026 (reported 29 July 2026): Hexvix/Cysview revenue NOK 140.0m (Q2 2025: 135.6m); product revenue +11% cc (North America +12% ex-FX, Europe +10% ex-FX). Total revenue NOK 142.5m. Adjusted EBITDA NOK 27.2m (~19% margin); reported EBITDA NOK -2.0m (pressured by Vesica investment/FX); EBIT NOK -9.4m. Cash NOK 162.4m, no term debt. Gross profit NOK 132.1m (~93% core product gross margin).
Q1 2026: Hexvix/Cysview revenue NOK 139.0m; adjusted EBITDA NOK 15.3m; total revenue NOK 264.6m (boosted by Asieris/Cevira milestones).
H1 2026 total revenue NOK 407.1m, including NOK 125.6m Asieris milestone revenue.
FY2025: total revenue NOK 532.6m; positive EBITDA with expanding commercial margins (7%→11% full-year commercial EBITDA margin).
Guidance: FY2026 product revenue growth raised to 8-11% cc (from 7-11%) with adjusted EBITDA margin expansion. Management’s long-term framing (per Q2 2026 presentation coverage) projected consolidated revenue growth above 25% p.a. 2026-2030 with Vesica included and adjusted EBITDA margin above 25% by 2030 — these are company projections, not results.
U.S. installed base (historical trajectory):
End-2019: 223 permanent BLC systems installed (+42% YoY).
End-2023: 352 rigid BLC systems (+17%).
End-2024: 390 rigid BLC systems (+11%), including 18 ForTec mobile towers; ~25 flexible BLC towers estimated remaining.
Through 2025: Q1 337 active accounts, Q3 373, Q4 384; ForTec mobile fleet grew to 24 towers. (prnewswire)
2026: Q1 413 active accounts (+21% YoY), (PR Newswire) Q2 436 active accounts (+20% YoY). Per the Q2 2026 call, ForTec mobile unit volumes were “up roughly 70% year over year,” now representing 17% of North American sales (versus 11% a year earlier) and supporting 200+ accounts and 350+ physicians across a 24-tower fleet.
Note the distinction between “installed rigid systems” and “active accounts”: Photocure shifted its disclosure emphasis to active accounts and increasingly to a mobile (OPEX) model via ForTec, which sidesteps hospital capital-equipment budgets.
Historical constraints on U.S. BLC adoption: (1) capital cost of the tower/light source; (2) single-supplier dependence on Karl Storz (a Class III PMA product) — reinforced when Karl Storz discontinued U.S. flexible BLC tower production in March 2023 over component supply issues; (3) reimbursement, addressed substantially when CMS introduced/expanded “complexity adjustments” for CPT 52000 and 52204 (HOPD payment for 52000 rose from $587.56 to $1,854.88 and 52204 from $3,140.04 to $3,205.12 effective Jan 2023; Cysview billed via A9589 and procedure code C9738; ASC adjustments added via C7554/C7550); (4) added OR time and incubation/instillation workflow; (5) urologist training. Reimbursement is now a relative tailwind; equipment access has been the binding constraint — which is exactly what reclassification addresses.
In-office/flexible surveillance opportunity. Cysview’s 2018 label expansion covers flexible cystoscopy for surveillance, a large recurring-procedure market. But this opportunity has been gated by the absence of flexible BLC equipment since Karl Storz exited U.S. flexible production in 2023. Photocure’s response: a co-development partnership with Richard Wolf (announced July 2024) for an HD flexible blue light cystoscope, plus interim flexible solutions. Reclassification is directly relevant to reviving the flexible/office surveillance channel. - Competitive and Market Landscape
Karl Storz’s position. Karl Storz has been the effective U.S. monopolist on BLC-compatible towers (the D-Light C / Saphira PMA lineage). Its exclusivity is the practical bottleneck reclassification targets. Notably, Karl Storz itself petitioned for reclassification — it benefits from reduced PMA-supplement burden even as the barrier falls for rivals. Karl Storz remains “fully committed” to Saphira.
Other/emerging device entrants. In Europe (where a CE-mark/lower-barrier regime already applies), the field is already broadening: Olympus launched its Visera Elite III BLC-capable system (87 EU installs since Q1 2025 launch by Q2 2026); Richard Wolf (System blue — the co-development partner for flexible); and Stryker (recently CE-marked BLC-compatible platform, early EU traction). Richard Wolf’s System blue was approved in China (April 2026, alongside Hexvix). (Photocure) The broader rigid-endoscope competitive set (Olympus, Stryker, Richard Wolf, Boston Scientific, Ambu, Pentax, Cook, plus Karl Storz) is exactly the pool of potential U.S. entrants once a 510(k) pathway exists. Photocure explicitly says it is “supporting multiple device manufacturers pursuing established alternative regulatory pathways.” (Photocure)
Adjacent/competing visualization technologies. Narrow band imaging (NBI, Olympus) is guideline-mentioned (AUA grade C) and needs no drug; IMAGE1 S / SPIES (Storz digital chromo-endoscopy); Cellvizio/confocal and OCT are niche. None has displaced BLC’s CIS-detection advantage, but NBI is a “free” (no consumable) alternative that competes for the enhanced-cystoscopy slot.
Urine biomarkers — the bigger structural question. Cxbladder (Monitor/Triage/Detect), Bladder EpiCheck, Xpert Bladder Cancer Monitor, ADXBLADDER, UroVysion (FISH), Uromonitor, and Vesica’s AssureMDx are non-invasive tests with high negative predictive value (frequently >95%) that can de-intensify or space out surveillance cystoscopy. Randomized data (e.g., DaBlaCa-15 with Xpert; STREAM with Cxbladder Triage) show 57-59% reductions in cystoscopy use in selected settings without compromising recurrence detection. AUA/SUO (2024) still says biomarkers should NOT replace cystoscopic surveillance, but the trajectory points to biomarker-integrated, risk-stratified surveillance. This is a more material long-term risk to BLC procedure VOLUME than device competition. Photocure has strategically hedged by acquiring Vesica Health (AssureMDx; multi-omic urine test; initial revenue expected 2027, reimbursement ~mid-2028) and partnering with Artera on AI digital pathology.
Razor/razorblade analysis — does device competition hurt or help?
Bull (dominant) case: Photocure sells the drug (razorblade), not the scope (razor). It earns ~93% gross margin on every vial regardless of which vendor’s tower is used. More vendors → more installed towers → more sites able to run BLC → more Cysview vials. Reclassification converts Photocure’s biggest structural constraint (equipment access) into a growth vector, and Photocure’s economics improve if hardware becomes cheaper/commoditized because that accelerates placements. This is why Photocure publicly welcomes the change. On the Q1 2026 release (7 May 2026), Schneider framed it directly: “For Photocure, reclassification has the potential to be a step-change driver for the business, unlocking a significantly larger commercial opportunity, as we move towards double-digit penetration across the expanded market relative to where we are today.”
Bear/nuance case: (1) Cross-labeling — each new device must be labeled for use with Cysview; if a competitor developed an alternative fluorophore or a “label-free” enhanced-imaging modality on a cheap Class II platform, that could bypass the drug. (2) Karl Storz has been an aligned, motivated commercial partner that co-marketed and co-funded adoption; a fragmented multi-vendor market could dilute that dedicated commercial push. (3) Commoditized hardware could compress the “premium procedure” positioning that underpins the CMS complexity-adjustment rationale. On balance, the bull case dominates: Photocure does not capture scope economics today, so it has little to lose and much to gain from more device supply. - Clinical and Guideline Context
AUA/SUO NMIBC Guideline (2024 Amendment): “In a patient with NMIBC, a clinician should offer blue light cystoscopy (BLC) at the time of TURBT, if available, to increase detection and decrease recurrence” (Grade B / Moderate Recommendation). NBI is mentioned (Grade C). The guideline also incorporated the PHOTO trial (UK, 538 patients), which found no significant difference in recurrence (HR 0.94; 95% CI 0.69-1.28) or progression (HR 1.41; 95% CI 0.67-2.96) at 44 months — a notable negative signal, though caveated because CIS (where BLC helps most) was present in only 13% of specimens and the trial was arguably underpowered. EAU and NCCN similarly recommend BLC, especially for positive cytology with negative white-light cystoscopy.
Evidence base. BLC’s strongest claim is improved CIS/flat-lesion detection. In the pivotal Richard Wolf “System blue” HD Phase 3 China bridging trial (published in Frontiers in Urology, 2025; also presented at AUA 2024), BLC detected additional lesions in 43.3% of patients versus white-light cystoscopy (p<0.0001); the CIS detection rate was 94.7% for BLC versus 42.1% for WLC, and 61.5% (8/13) of CIS cases were “diagnosed solely by BLC.” Recurrence-reduction evidence is mixed (positive meta-analyses and the VA BRAVO real-world analyses showing reduced recurrence/progression versus the null PHOTO trial). Cost-effectiveness is contested; Photocure’s recent BRAVO and OPTUM real-world studies argue “cost neutrality” via reduced recurrence. Progression/long-term survival benefit remains debated.
Safety. Cysview/hexaminolevulinate has a long real-world safety record; FDA explicitly did NOT identify technology safety concerns in its 2026 reclassification feedback, and the reclassification rationale itself rests on the absence of significant post-market safety signals for the device. The drug label carries standard risks (e.g., hypersensitivity/anaphylaxis risk, extravasation). No material FDA safety signal history has derailed the franchise. - What to Watch / Leading Indicators
Near-term regulatory milestones:
The Federal Register proposed order’s docket number and the public comment deadline (typically 60-90 days after publication). Watch regulations.gov for the OAY docket.
Any device classification panel meeting.
The final order and its effective date (base case 2027-2028).
First new 510(k) clearances for BLC-capable systems (Olympus, Stryker, Richard Wolf are the likeliest U.S. entrants).
Company KPIs:
Quarterly U.S. active accounts (436 at Q2 2026) and Saphira tower installs/upgrades; ForTec mobile fleet size and mobile % of North American sales (17% at Q2 2026).
Rigid kit vs. flexible kit unit sales; reintroduction of a flexible BLC solution (Richard Wolf).
Cysview vial/kit volumes and North America vs. Europe growth split.
Vesica/AssureMDx commercialization (initial revenue 2027, reimbursement ~mid-2028) and any biomarker reimbursement developments.
Reimbursement: continued CMS complexity adjustments in annual OPPS/ASC rules.
Asieris arbitration (Cevira milestone dispute) — a swing factor in reported revenue.
Rough quantification (with heavy uncertainty). Photocure states it serves less than 10% of its addressable U.S. market (an addressable pool often framed around ~300,000 TURBT procedures plus ~1.4m annual surveillance cystoscopies). U.S. active accounts (~436) versus tens of thousands of urology sites illustrates the runway. If reclassification enables 2-4 additional OEMs and roughly doubles the placeable installed base over 3-5 years, and utilization holds, a plausible (illustrative, not a forecast) outcome is high-single-digit to low-double-digit incremental annual U.S. volume growth layered onto the existing trajectory — i.e., the difference between a company growing product revenue ~8-11% and one able to sustain mid-teens+ for several years. This is contingent on OEM entry actually materializing, flexible/office BLC reviving, and biomarkers not cannibalizing surveillance volume faster than BLC expands. Management’s own >25% consolidated growth ambition to 2030 includes Vesica and milestones and should be treated as an aspiration, not a base case.
Market reaction / analyst view. The precise same-day PHO share reaction to the 14 August 2026 disclosure could not be confirmed from available sources; PHO traded roughly in the NOK 55-67 range through mid-2026, ~15-30% below its 52-week high (NOK ~79.8). Consensus was constructive: a ~NOK 82.5-84 average 12-month target and “Buy”/“Strong Buy” consensus from a small analyst pool; DNB Carnegie reportedly raised its target to NOK 80 (from 75) in May 2026, reiterating Buy. (Nordnet) Coverage is thin (3-4 analysts), so single-broker moves matter.
Recommendations
Treat the 14 August 2026 disclosure as a confirmatory, medium-term-positive milestone, not a near-term earnings catalyst. The proposed order starts a multi-quarter clock. Base case: final effective order 2027-2028. Do not expect P&L impact in FY2026-2027.
Anchor the thesis on the razor/razorblade logic. The correct lens is: does reclassification increase the number of U.S. sites that can run Cysview? Yes. That is unambiguously good for a ~93%-gross-margin drug franchise that captures none of the scope economics.
Track three leading indicators as the real proof points: (i) the Federal Register comment deadline and any panel meeting; (ii) the first competing OEM 510(k) clearance / U.S. launch (Olympus, Stryker, Richard Wolf); (iii) quarterly active-account and ForTec mobile growth. If, by end-2027, no final order and no new OEM entrant has appeared, discount the catalyst.
Weigh the biomarker threat as the more important structural variable. Monitor Vesica/AssureMDx execution and any guideline shift toward biomarker-based surveillance de-intensification. Reclassification expanding device access could be partially offset if surveillance-cystoscopy volumes structurally decline.
Thresholds that would change the view: Bullish escalation — a final order in 2027 plus ≥2 new OEM U.S. launches and a flexible BLC relaunch. Bearish — FDA panel demands new clinical trials (stalling the order), another negative BLC outcomes trial, or accelerated payer adoption of biomarker “rule-out” surveillance that shrinks cystoscopy volume.
Caveats and Bear Case
What is confirmed vs. inferred. The reclassification action, product code (OAY), legal basis (§513(f)(3)), the March/April/August 2026 chronology, the PMA lineage (P050027), the financials, installed-base numbers, guideline positions, and reimbursement codes are confirmed from primary/company sources. The exact Federal Register docket number, comment deadline, and the verbatim CEO quote in the 14 August release could not be independently retrieved; the specific special controls FDA will impose are not yet public. The same-day share-price reaction and detailed Norwegian broker notes could not be confirmed.
Bear case. (1) Timeline risk — reclassification could stall if FDA convenes a panel demanding new clinical data. (2) The PHOTO trial’s null result and contested cost-effectiveness could cap guideline enthusiasm and payer generosity. (3) Urine biomarkers may erode surveillance cystoscopy volume faster than device access expands it — the “the whole procedure category shrinks” risk. (4) Even with a 510(k) pathway, OEMs must still choose to build cross-labeled BLC systems and commit commercial resources; entry is not guaranteed. (5) Photocure is a thinly-covered small-cap (market cap ~NOK 1.6-2.0bn) with lumpy milestone revenue, an Asieris arbitration overhang, Ipsen earn-out and Vesica deferred-payment obligations (~NOK 193m), and reported (vs. adjusted) EBITDA currently negative due to investment spend. (6) Loss of the aligned single-partner (Karl Storz) commercial push in a fragmented multi-vendor market is a modest offsetting risk to the bull case.
Correction to the user’s draft framing. The reclassification “validates BLC and lowers barriers for competitors” — but the competitors are DEVICE makers whose scopes still require Photocure’s drug. It is far more a moat-neutral/tailwind event than a competitive threat to Photocure. The real competitive threats are non-drug modalities (NBI) and, more importantly, urine biomarkers. Two further precision fixes to the draft: (a) FDA did not simply “conclude sufficient evidence” — it initially declined the Karl Storz petition in March 2026, requesting more clinical evidence and stronger special controls, then chose to proceed on its own initiative; (b) the entity reclassified is code OAY (the light-source/imaging system), never Cysview itself.
This analysis is for information only and does not constitute investment advice or a recommendation to buy or sell any security.
Går ikke ann å få høydeskrekk midt i kjellertrappa vel?
Samme her 
Om det hjelper…
Er denne meldingen viktigere enn Cevira-godkjenningen - jeg bar spyr 
. Ps. Har ikke solgt, og selger ikke under 150 - og der kommer vi før eller siden .
Spyr eller spør?! 
Helgen ble plutselig enda bedre 
Blir bobler i kveld 
hm så det var en grunn for denne omsettningen en så idag altså.
Når kan reklassifiseringen faktisk tre i kraft?
Dokumentet du ser på er et forslag (“proposed order”). Det betyr:
- Publisering av forslaget – Dokumentet skal publiseres i Federal Register 17. august 2026. – Etter publisering åpnes en 60-dagers kommentarsperiode der alle kan sende inn innspill.
- FDA vurderer alle kommentarer – Dette kan ta alt fra noen uker til flere måneder. – Først når FDA er ferdig med vurderingen, kan de utstede en final order .
- Ikrafttredelse – Dokumentet sier eksplisitt: “FDA proposes that any final order … become effective 30 days after the date of its publication in the Federal Register.”
Dermed:
- Tidligst : ca. 30 dager etter at FDA publiserer den endelige ordren.
- Realistisk : 3–9 måneder etter 17. august 2026, avhengig av hvor raskt FDA behandler kommentarene.
Ja, dette er jo akkurat det vi diskuterte forrige fredag også !
Prøvde å selge dette påfyllet i dag, men glad nå for at den ikke ble plukket🙏
Noen som har en formening om forventet timeline fra proposed til final order? Og timeline på 510k?
Edit:
Så denne nå🙃
Ja spør - en nokså standard omskrivning det. Var det ikke morsomt
Ja det var morsomt, og bra spørsmål, jeg har ikke peiling på godt svar 
Dette var perfekt opplegg… få PHO i “holddegunna” porteføljen… og få en skremmemelding fra Asieris… og vipps fikk man kjøpt billig PHO aksjer som nå trolig kan vise til vekstcase på flere ben - cevira, flex, flere BLC scope leverandører i usa, Vesica oppkjøpet, mulig forbedret refusjon i US, satsinger på nye EU land og BLC og neste år blir earn-out for Ipsen halvert. Jeg sitter lastet med PHO som største investering… fylte på litt i duppen også… dessverre alt for lite sett i etterkant