Bavarian Nordic — Oktober 2022
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Lægen der ringede i tirsdags sagde 6 mdr studie
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Og de skal jo netop bruge længere data for at kunne begunde at bava vaccine holder længere end pfizer
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De er kommet lat lat for sent i gang hvis de på nogen som helst måde skal kunne præsentere indledende data i dec. Jeg tor mere man riisikere data ikke er konklusive. Og så er man sq lidt fucked. Aktien bliver det i hvert fald
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ahhh det er en ret kraftig overdrivelse. Pfizeers jhar så absolut virket!. Effekten fader "blot" for hurtigt. Det er DET der er bava fokus
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Og den ENESTE måde bava kan påvise den fordel er jo netop ved længere studier. Og lægen gjorde meget ud af at fortælle mig jeg SKAL komme ud til dem 7 gange over 6 mdr
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..de havde langtidsstudie på fase 2, som påviste durability...
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Bloomberg g.d. "Moderna Nears US Deal to Develop Shots for Ebola, Other Biological Threats" https://www.bloomberg.com/news/articles/2022-10-26/moderna-mrna-nears-us-deal-to-develop-shots-for-range-of-biological-threats?sref=3qGOTMF4
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WT det er på meget få patienter. Så de data kommer myndighederne ikke til at lægge ret meget vægt på. Det er derfor man har fase 3 studier
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(fort.) Bloomberg "The contract will see Moderna work with researchers from the University of Texas Medical Branch at Galveston to build on the company’s mRNA technology that was used to rapidly make Covid-19 vaccines, according to people familiar with the situation who were not authorized to speak on the deal because it has not yet been finalized."
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Jojo Troldmand, men godkendelse hviler stadig på et endpoint at den ikke er ringere end contamity..
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Men vi må se, hvad der sker i december...
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A global Phase 3 trial assessing the non-inferiority of ABNCoV2 compared to Comirnaty
in terms of neutralizing antibodies against the SARS-CoV-2 index virus was initiated in September 2022. The double-blind, controlled trial will enroll two groups of a total of approximately 4,000 adult subjects who either previously completed primary vaccination or have already received one booster dose of a licensed COVID-19 vaccine. The first group, which is currently enrolling in the U.S., will evaluate the -
will evaluate the safety and tolerability of the vaccine in 3,000 subjects receiving a single 100 µg dose of ABNCoV2. The second group will start enrollment of 1,000 subjects in Denmark and Belgium later in October. Subjects in this group will be randomized to receive either a single 100 µg dose of ABNCoV2, or a single 30 µg adult booster dose of Comirnaty.
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måske de 6 mdr. startede i september?
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De 6 mdr starter altidfra sidste patient er indrulleret. Ellers kan man jo ikke få 6 mdr data for alle patienter. Man kan godt vælge at lave nogle samples undervejs. Men det øger typisk risiko for det fulde studie. Så det er primært i cancer den slags benyttes
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..som jeg læser det, kan de søge om godkendelse så snart primær endpoint er nået...6 mdr. data vil afgøre hvor stort marked de kan få...
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