Filing q4 tipper jeg?
Yes, jeg har fortsatt aksjene mine. Økte på dippen etter pracinostat ble avsluttet.
Gårsdagens kvartalsrapport:
https://seekingalpha.com/article/4373418-mei-pharma-inc-meip-ceo-dan-gold-on-q4-2020-results-earnings-call-transcript?page=1
De sier blant annet dette:
Planlagt fase 3 studie med oppstart i 2021
“Further, we are currently in discussions with the FDA on the design of a global randomized Phase 3 study in patients with follicular and marginal zone lymphoma in combination with rituximab that we look forward to initiating sometime mid-2021. This study is intended to serve as a confirmatory study for title NDA under the accelerated approval pathway. It is also intended to support regulatory marketing approvals in other geographies.”
Ny kohort innen MZL med mulighet for filling hvis gode data
"We believe this best optimizes the potential for zandelisib for patients and provides value to our investors. As an example of this shared vision, I can announce today that we have filed an amendment to the title study to evaluate zandelisib as a monotherapy in patients with marginal zone lymphoma who have received two prior lines of therapy. We expect the enrollment to commence by around year-end, similar to our approach with the title study in third line follicular lymphoma.
We are also considering the accelerated approval pathway for third line marginal zone lymphoma indication if supported by the data. I should point out that this new arm in the title study will not affect our plans to file on the follicular lymphoma patients, if the data warrants such. In addition to expanding the potential utility of zandelisib as mentioned above MEI retained the right to book U.S. sales, providing a foundation to extend the company’s capabilities and build-out our commercial capability."
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De guider forøvrig top-line 6 mnd data i løpet av høsten 2021 fra TIDAL-studien.
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What NANO could have been…
Estimert 60 pasienter i MZL, med sikte på AA om data tillater det.
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Sykt spennende med potensielt registreringstudie i mzl. Vil bruke de aktive sitene i TIDAL. Over 100 sites. 60 ish pasienter. Kan gå særs hurtig
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Oppdatert studiesite for me-401, nå med en kohort på 60 pasienter med MZL - tjuvtriks å få disse inn i en studie med allerede aktiverte sites.
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Tenker høyt her, men vet vi sånn noenlunde timeline for Zandelisib i MZL? FPD forventet rundt nyttår, innrullering tar 12mnd ish og top-line data 6 mnd senere?
MZL høyst spekulativ timeline blir da;
FPD Q12021
Enrolment complete Q12022
Top-line data Q32022
Filing sent i Q42022
I 2023 har sannsynligvis Meip Zandelisib godkjent i 2 indikasjoner, samt sannsynligvis også mange nye indikasjoner i klinikk.
Fpd på plass for mei/kk i Japan.
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Guider fremdeles på å ha TIDAL ferdig innrullert ila. Q1 2021.
Konkluderer også at MZL er bakt inn i studiet og vil omfatte 60 pasienter. Samtidig ser de for seg oppstart av fase III mid 2021 - mistenker at denne blir i kombinasjon med Rituximab.
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MEI PHARMA INC
MEI PHARMA INVESTIGATION INITIATED by Former Louisiana Attorney General: Kahn Swick & Foti, LLC Investigates the Officers and Directors of MEI Pharma, Inc. - MEIP (Businesswire)
2020-12-19 04:50
Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF has commenced an investigation into MEI Pharma, Inc. (NasdaqGS: MEIP).
From August 2017, the Company repeatedly touted the potency and effectiveness of its drug candidate, Pracinostat, in its Phase 2 trial. However, on July 2, 2020, the Company disclosed that it was discontinuing the Phase 3 trial of Pracinostat, due to an interim futility analysis of the study that “demonstrated [Pracinostat] was unlikely to meet the primary endpoint of overall survival compared to the control group.”
Thereafter, the Company and certain of its executives were sued in a securities class action lawsuit, charging them with failing to disclose material information during the Class Period, violating federal securities laws, which remains ongoing.
KSF’s investigation is focusing on whether MEI’s officers and/or directors breached their fiduciary duties to MEI’s shareholders or otherwise violated state or federal laws.
If you have information that would assist KSF in its investigation, or have been a long-term holder of MEI shares and would like to discuss your legal rights, you may, without obligation or cost to you, call toll-free at 1-877-515-1850 or email KSF Managing Partner Lewis Kahn (lewis.kahn@ksfcounsel.com), or visit https://www.ksfcounsel.com/cases/nasdaqgs-meip/ to learn more.
Dette er visstnok bare støy, det hagles ut med disse meldingene fra diverse lyssky virksomheter.
Denne presentasjonen er kanskje litt interessant =)
https://seekingalpha.com/article/4374966-mei-pharma-meip-presents-h-c-wainwright-22nd-annual-global-investment-conference-slideshow
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Ser det er flere investorer rundt om som venter på data fra Voruciclib tidlig i 2021. Dette har muligens gått meg hus forbi, men absolutt spennende å endelig få kliniske effektdata herfra.
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Fastholder guiding mot slutten av Q1. Spenstig det?
Jepp, jeg likte dagens melding. Er igang med MZL armen i TIDAL ila Q1 også. Voruciclib data lar dog vente på seg. Litt kjipt.
Noen som fremdeles er med?
Ser ut som det begynner å buldre, spennende frem mot sommeren med nye data og guidet i januar ferdigrekruttert i løpet av q1. Fremdeles en god pengesekk og med god driv i studiene sine.
Håper forsåvidt den holder seg nede en stund til da jeg helst vil øke posisjonen. At KK gikk inn balls deep og at studien har pågått uten hickups tyder på at ting er i rute også effektmessig, blir spennende å sitte over resultatene fra et pivotalstudie - det jeg vil tro er det mest binære punktet i en bingoaksjes liv.
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Er fortsatt med her jeg også. Er vel earnings her også imorgen etter close? Så lenge de ikke sier noe om at enrolment completed sklir ut i q2, tror jeg vi er good og at man kan se et fint driv fremover
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