Tipper fokuset til RFK kommer til Ă„ bli mRNA-vaksiner, og ikke Medical Devices.
4 Likes
Flere er inne pÄ at det ikke er garantert at Cevira blir godkjent. Er det noen kjente sider ved Cevira som skulle kunne gi grunnlag for Ä ikke gi godkjenning?
Det er da ingen som forbyr noen Ä grave litt dypt i lomma. Men det bÞr jo vÊre lov Ä Ä stille et spÞrsmÄl om det. IsÊr pÄ bakgrunn av de siste dagers meldinger.
1 Like
Nei nÄ mÄ vi grave dypt i lomma og kjÞpe aksjer, skal vi fÄ fart pÄ PHO mÄ det flere kjÞpere til. Ikke mer konspirasjon og fanden pÄ veggen problematikk.
Det har vĂŠrt mye diskusjoner de siste dager. Jeg synes det skal vĂŠre rom for flere meninger og syn enn bare det som faller innenfor kategorien haussing. Samtidig kan det fort ende opp med Ă„ bli kverulering og gjentakelser. Det tar jeg selvkritikk for.
NĂ„r man er investert i et selskap er det like viktig Ă„ unngĂ„ Ă„ tape penger som Ă„ tjene dem. Da synes jeg de som investerer mĂ„ ha et sĂ„ nyansert bilde som overhode mulig. Man skal ikke skyte budbringeren eller âta mannenâ - og det gĂ„r begge veier.
Det er et faktum at FDA har nedprioritert nedklassifiseringen, og det har ikke hjulpet at det er valgÄr. Da er det relevant Ä se mot 2025 og ny administrasjon.
Det var et behov Ă„ utfordre tolkninger av Asierisâ CEO sine utsagn her inne
Og til slutt er det nÞdvendig Ä pÄpeke det er fremdeles risiko med Cevira og sannsynlighet for godkjenning, - selv om den er lav.
PÄ Ultimo-trÄden fikk personer komme med utsagn som at det var 99% sannsynlighet for positiv avlesning av den ene studien - uten at det i stor nok grad ble utfordret.
Men Q4 blir fremdeles spennende for Asieris. De skal ha samtaler med EMA angÄende mulig sÞknad der. De kan ha samtaler med potensielle partnere i USA for videre utviklingslÞp der. De kan ha etablet nye samtaler med NMPA i lys av fokuset pÄ CIIC. 
Men Cevira blir ikke godkjent i morgen 
6 Likes
à si at Cevira ikke blir godkjent i morgen er like dumt som Ä si at Cevira BLIR godkjent i morgen. INGEN vet nÄr Cevira blir godkjent.
2 Likes
Beklager om dette har vĂŠrt diskutert fĂžr, men jeg prĂžver igjen:
Er det noen kjente politiske eller medisinske sider rundt Cevira som skulle kunne gi logisk forklaring pÄ et eventuelt avslag pÄ sÞknaden? For et eventuelt avslag mÄ vel begrunnes?
Det ved du sÄ ikke NOGET om, men jeg giver dig fuldstÊndig ret 
OgsĂ„ enig i at man i denne âventetidâ gerne mĂ„ udfordre diverse fortolkninger, men det bĂžr gĂžres med noget rimeligt konstruktivt - da kun jamren eller kun hurrarĂ„b i min verden ikke bidraget til noget som helst.
Ser dig som en af de konstruktive.
Hele setuppet som Asieris er igang med omkring Cevira er ret sÄ grundigt, fornemmes meget seriÞst og vÊrdien af deres forskellige samarbejdspartnere, gÞr at jeg har stor tiltro til at der kommer en endelig godkendelse.
PrÊcis hvornÄr er jeg lidt usikker pÄ, til gengÊld er jeg sikker pÄ, at nÄr den er givet, sÄ vil udrulningen ske ret sÄ hurtigt.
5 Likes
Om PHO var Amerikansk?
Last Price NOK 53.00
Fair Value NOK 407.96
87.0% undervalued
(Simply Wall Street)
2 Likes
Kina (NMPA) har tilsvarende som beryktede Complete Response Letter fra FDA kalt âDeficiency Noticeâ. Og det mĂ„ begrunnes ja.
StÄr litt om det her:
3 Likes
AngÄende Richard Wolf Photodynamic Diagnostic Equipment sÞknaden her er svaret jeg fikk fra pho om det.
The Chinese submission for the Richard Wolf equipment went in about 6 months after the Hexvix application. So perhaps a 6 month delay from the expected Hexvix timeline which was 1H 2025. So conservatively 2H 2025 for PDD equipment approval but maybe the regulators move more quickly. That is the best information we have currently.
David
SĂ„ skal en fĂžlge hva pho guider sĂ„ forventer jeg mye positivt fra kina neste Ă„r i 2q . Som vanlig i pho er at TTT⊠ting tar tidâŠ
Det som jeg tror er viktig Ä se etter i dette kvartalet er Ä se om fortec avtale er sÄ positivt som de har sagt den vil vÊre. Kanskje litt tidlig men jeg er utÄlmodig.
9 Likes
Aksjemarkedet er som kjent en arena der pengestrÞmmen gÄr fra de utÄlmodige til de tÄlmodige 
1 Like
Signeringer og avtaler fortsetter Ă„ bygge seg opp.
12 Likes
Yahong Hong Kong signed a strategic cooperation agreement with Shanghai Pharmaceutical Science Park Trading at the Expo
2024-11-07/Press release
On November 7, Yahong Hong Kong (hereinafter referred to as Yahong) and Keyuan Xinhai (Beijing) Medical Supplies Trading Co., Ltd. (hereinafter referred to as Shanghai Pharmaceutical Science Park Trading) officially signed a strategic cooperation agreement at the 7th China International Import Expo. After the approval of APL-1702, Yahongâs core product, the two parties will carry out comprehensive cooperation in import agency, bonded area services, warehousing and logistics, and channel distribution, and make full use of the advantages of both parties in their respective fields to jointly accelerate the commercialization process of APL-1702 and benefit Chinese patients as soon as possible.
Photo: Yahong Hong Kong and Shanghai Pharmaceutical Science Park Trade signed a strategic cooperation agreement at the Expo
Yahongâs APL-1702 is currently the worldâs first non-invasive treatment for cervical precancerous lesions that has been clinically validated by international phase III clinical trials and has definite efficacy, so that patients with cervical precancerous lesions no longer have only âone-size-fits-allâ surgical therapy, and is expected to reverse the disease process and better cope with recurrence on the premise of preserving the intact cervix, filling the gap in non-invasive treatment. While contributing to the goal of eliminating cervical cancer, it also protects womenâs fertility so that the elimination of cervical cancer does not have to come at the expense of cervical eradication. The NDA for this product was accepted by the National Medical Products Administration in May this year.
Chu Chenxi, chairman and general manager of Shanghai Pharmaceutical Science Park Trade, said: Yahongâs innovative spirit coincides with Shanghai Pharmaceutical Science Park Trade. We are also excited about the opportunity to help patients get access to this innovative treatment faster." Shanghai Pharmaceutical Science Park Trading is very willing to share its own resources and advantages with Yahong, and at the same time provide the most suitable service solutions for partners, it hopes to bring the worldâs first non-invasive non-invasive product for the treatment of cervical precancerous lesions to Chinese patients faster.
Cao Shaohua, senior vice president and head of the womenâs health business department of Yahong, said: The new drug application of Yahong APL-1702 has been accepted, and the company is actively promoting the marketing review and approval of the product, which is currently progressing smoothly. Through external collaboration, we look forward to accelerating the launch of innovative products and continuing to expand access to medicines." We are excited to partner with an industry-leading company to bring this innovative product in the field of cervical precancerous lesions to patients as soon as possible, with a view to bringing this innovative product to patients as soon as possible."
Chu Chenxi, chairman and general manager of Shanghai Pharmaceutical Science Park Trading Co., Ltd., and Zhang Lin, assistant general manager; Cao Shaohua, Senior Vice President of Yahong and Head of Womenâs Health Division, Guo Hui, Senior National Commercial Director and other relevant leaders attended the signing ceremony.
About Shanghai Pharmaceutical Science Park Trading:
Shanghai Pharmaceutical Science Park Trading is a core pharmaceutical import and distribution enterprise of Shanghai Pharmaceutical Holdings under Shanghai Pharmaceutical Group (ranked on the Fortune Global 500 for many years), and is a large-scale comprehensive service-oriented pharmaceutical enterprise integrating import bonded, pharmaceutical circulation, vaccine services, digital marketing, market access, supply chain extension services, etc., providing more valuable one-stop import solutions for many well-known pharmaceutical companies around the world, importing more than 230 specifications of drugs and vaccines, and a distribution network covering 31 provinces across the country. Municipalities and autonomous regions, covering more than 1,300 distributors, more than 2,300 district and county centers for disease control and prevention, and more than 100,000 retail pharmacies, provide professional services for global customers with excellent advantages and rich resources.
About Asia Hong Kong:
Adhering to the corporate mission of âImproving Human Health and Making Life More Dignifiedâ, Yahong Hong Kong is a global innovative pharmaceutical company focusing on R&D, production and commercialization in the field of therapeutic treatment, and providing the best integrated diagnosis and treatment solutions for patients in China and around the world.
10 Likes
Takk som deler.
Det som er litt rart er at det ikke finnes offisiell informasjon om spesifikke designasjoner for sĂžknaden for Cevira. Ingenting om innovativ, prioritert eller fast-track-designasjon.
Men det alle disse nye avtalene peker pĂ„ er strategisk arbeid rundt livmorhalskreft i Kina for mest mulig informasjons-flyt- og deling, utbredelse og samarbeid - og ikke minst Ăžke oppmerksomheten til, for ikke Ă„ si âpressâ mot NMPA.
5 Likes
Tror den ryker tbh, 56 og. SkjĂžnner ikke helt risk/reward i Ă„ drive og selge ned det her, men de har vel en tanke med det.
4 Likes
Leaders of the National Health Commission visited and provided guidance
Shanghai, China, November 7, 2024 - At the 7th China International Import Expo ( CIIE ) , Asieris, a global innovative pharmaceutical company , participated in the exhibition for the first time and, together with many partners, launched the first real-life exhibition of an innovative prevention and control system to accelerate the elimination of cervical cancer in the Innovation Incubation Zone, which attracted a lot of attention.
Deputy Director of the Population, Resources and Environment Committee of the 13th National Committee of the Chinese Peopleâs Political Consultative Conference, Chairman of the Academic Committee of the Institute of Health and Population Development Strategy, and former Deputy Director of the National Health and Family Planning Commission, He Dan, Member of the National Committee of the Chinese Peopleâs Political Consultative Conference, Director of the China Population and Development Research Center, and Chairman of the Healthy China Research Center, Gang Ge, Deputy Director of the Health Development Research Center of the National Health Commission, and other leaders visited the booth and listened to the introduction of the full-chain prevention and control of cervical cancer. They focused on understanding the innovative product APL-1702 for the non-invasive treatment of cervical precancerous lesions, which was brought by Yahong for the âglobal debut and Chinaâs first exhibitionâ.
APL-1702 is the worldâs first photodynamic drug-device combination product for the non-invasive treatment of cervical precancerous lesions that has been verified in an international Phase III clinical trial. It is expected to subvert the traditional surgical treatment pattern, preserve the integrity of the female cervix while treating the disease, protect female fertility while accelerating the elimination of cervical cancer, and help China take the lead in achieving fertility-friendly cervical cancer prevention and control.
The leader of the National Health Commission pointed out that cervical cancer is a major disease that endangers womenâs health. Its prevention and control work is arduous and long-term, and requires the efforts of multiple sectors of society to jointly contribute to the early realization of âfertility-friendlyâ cervical cancer prevention and control and the Healthy China strategy.
Photo: A delegation of leaders from the National Health Commission visited and provided guidance
11 Likes
1 Like
HÄper at alle disse samarbeidsavtalene tyder pÄ at produktet er lett Ä forstÄ og en «no-brainer»
1 Like
Av den millionen det er handlet for i dag, hvor mye av disse kr tilhĂžrer TI banden?
Kursen gÄr ikke fÞr dette er bekreftet,
Ă
etter det, gÄr den tilbake igjen, i pÄvente at dette skal omsettes, Ä gi kr i kassen.
( Cysview er vel et eksempel pÄ at det ikke trenger Ä gÄ fort 
)
Eâz on the FOMO boys, hjelper ikke Ă„ sende hverandre hause klipp fra weben 
Snakkes pÄ femtilappen 