Mi scuso per l'invasione.
Io ho chiuso il blog per motivi di lavoro e, credetemi, non è facile rinunziare ad uno spazio frequentato da oltre 150mila persone.
Non ho più tempo. Ho risposto a svariate migliaia di domande. Tutti hanno avuto una risposta. Oggi è veramente offensivo essere criticato perchè non riapro il mio blog. Il mio era un servizio che non era dedicato a Cell.
Da quando nel blog si inserì un dipendente di CTI la cosa cominciò ad affascinarmi come un romanzo di John Grisham.
Ad ogni modo, se oggi avessi parlato di Cell vi avrei detto che Bianco ha venduto le sue 10mila azioni mensili, come da piano fiscale. Per il resto, tutto il management non ha venduto neppure un titolo, sin dall'aprile 2011.
Prima vendevano ogni mese!
Interssante che Bianco si rifiuta di commentare l'aver ritirato la NDA dalla FDA.
Vi allego un estratto dal Form K8 di oggi per una vostra lettura.
Cordiali saluti a tutti e scusate, ancora, l'invasione.
Regulatory Matters and Products in Development
Pixantrone
a) Marketing authorization process in U.S.A.
On October 25, 2011, the Company announced the resubmission of the New Drug Application for pixantrone (“NDA”) to the U.S. Food and Drug Adminisitration’s (the “FDA”) Division of Oncology Products 1 (the “DOP1”) for accelerated approval to treat relapsed or refractory aggressive non-Hodgkin’s lymphoma (“NHL”) in patients who failed two or more lines of prior therapy.
On December 6, 2011, the Company announced that the FDA’s DOP1 had notified the Company that the Company’s October 2011 resubmitted NDA is considered a complete, Class 2 response to the FDA’s April 2010 complete response letter (“CRL”). The FDA has set a Prescription Drug User Fee Act (“PDUFA”) goal date of April 24, 2012 for a decision on the NDA.
On January 3, 2012, the Company announced that the FDA’s Oncologic Drugs Advisory Committee (“ODAC”) was scheduled to review the Company’s resubmitted NDA for pixantrone on February 9, 2012.
On January 30, 2012, the Company announced that it had voluntarily withdrawn its NDA for pixantrone. The NDA was withdrawn because, after communications with the FDA, the Company needed additional time to prepare for the review of the NDA by the FDA’s ODAC at its February 9, 2012 meeting. Prior to withdrawing the NDA, the Company requested that the FDA consider rescheduling the review of the NDA to the ODAC meeting to be held in late March. The FDA was unable to accommodate the Company’s request to reschedule, and given the April 24, 2012 PDUFA date, the only way to have pixantrone possibly considered at a later ODAC meeting was for the Company to withdraw and later resubmit the NDA. The Company plans to resubmit the NDA in 2012.
b) Marketing authorization process in Europe
On December 5, 2011, the Company announced an update on the status and progress of its European marketing authorization application (“MAA”) for pixantrone. The Company received the European Medicines Agency’s (the “EMA”) Committee for Human Medicinal Products (“CHMP”) day 180 list of outstanding issues, which unlike the day 120 letter, contained only one remaining major objection to the Company’s MAA and items not deemed to be major issues. To address the remaining major objection, the CHMP required that the Company provide a literature review of mechanisms of rituximab resistance and analyses that demonstrate the efficacy of pixantrone in patients with prior rituximab treatment, as well as information to address some additional questions that were not deemed to be major issues and could be addressed by additional analyses of currently available data.
On January 20, 2012, the Company announced that following discussions with the CHMP, the CHMP may issue an opinion on the Company’s MAA for pixantrone in mid-February. In the interim, the Company will continue to work with the CHMP on the Summary of Product Characteristics and other labeling items for pixantrone.
guardarsi prima in casa propria !
