For alle gÄr rundt og husker hva som ble sagt i hvilken kvartalspresentasjon
Asieris News ( IKKE Cevira relatert)
Fra om Asieris ::
Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and womenâs health. We strive to improve human health to preserve patientâs dignity. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide.
The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus.
Eller nisje segment, som vise analytikere kaller det.
En kinesisk nisje = rundt regnet 250 norske nisjer
Norne?
31/7-01/8 solgte;
THE BANK OF NEW YORK MELLON SA/NV
123.300 aksjer.
De er nÄ pÄ 13 plass blant topp 20 med 302.900 aksjer.
Ikke rart at aksjekursen faller.
Det var store fond som kjÞpte pÄ Q rapport, sjekk liste!
Jeg har tilgang pÄ Norne. Jeg vil jo tro at de er pÄlitelige.
Ja, handelen stemmer den. Poenget mitt var at store fond kjĂžpte
Oi oi.
Noen som vet hva andre runde innebĂŠrer?
What âSecond Round of Supplementary Reviewâ Implies
If a drug is in the second round , it typically means:
- First Round Response Was Insufficient : The sponsor submitted responses to the first round of supplementary questions, but the CDE still has unresolved issues or new questions.
- Ongoing Communication : The CDE is giving the sponsor another opportunity to provide clarifications or more complete data.
- Review Is Continuing, Not Rejected : It is not a rejection â the drug is still under active review , and the agency is engaging with the sponsor to address concerns.
- Common in Complex Applications : This is common for innovative drugs, especially Class 1.1 new drugs or biologics , where data packages are large and complex.
Etter hva jeg finner pÄ nett om det sÄ betyr det at de nÄ reviewer den supplimentet som ble sendt inn.
I fare for Ă„ pĂ„dra meg vreden fra enkelte her innpĂ„ sĂ„ skal jeg vĂŠre forsiktig med Ă„ synse for mye, men jeg tror etter hva jeg finner om det at det betyr âden er nĂ„ Ăžverst i bunken og in progress for final check av innsendt materialeâ.
Her mÄ nok litt mer kunnskapsrike folk pÄ banen. @Haltopen maybe?
Post pÄ Kinaforum:
â1702 has passed the second round of review and is now reliable. It will be on the market soon!â
Aksjen reagerte raskt hvertfall
Har samme oppfatning. CDE har nÄ startet pÄ review av supplementary information - som er positivt! Neste spÞrsmÄl er jo hvor lang tid de bruker. Skulle tro det nÄ er god sannsynlighet for svar innen de opprinnelige 60 arbeidsdagene.
ByggesĂžknad er flyttet fra bunken til pulten
jeg fĂ„r opp pĂ„ Perplexity; âand it is a critical step before administrative approval and final market authorizationâ