TGTX
Claro que dicen para 2 años...están estimando gastos mínimos para sus estudios más avanzados, incluyendo la opción de aprobaciones aceleradas. Luego en la realidad, como es habitual, no va todo tan perfecto, aparecen problemas o contratiempos y el gasto estimado se acaba disparando:
COSTS AND TIME TO COMPLETE PRODUCT DEVELOPMENT
The information below provides estimates regarding the costs associated with the completion of the current development phase and our current estimated range of the time that will be necessary to complete that development phase for our key pipeline products. We also direct your attention to the risk factors which could significantly affect our ability to meet these cost and time estimates found in this report in Item 1A under the heading “Risks Related to the Company’s Business and Industry.”
TG-1101 (ublituximab) In combination with ibrutinib in previously treated high-risk CLL patients Phase III 2017* Approximately $10 million
TG-1101 & TGR-1202 In combination in CLL patients Phase III 2018** Approximately $15 million
*Completion of phase for this study indicates completion of Part I of the study, the ORR endpoint, which, if successful, would support an accelerated approval
** Completion of phase for this study indicates completion of portion of study, which, if successful, would support an accelerated approval
Completion dates and costs in the above table are estimates due to the uncertainties associated with clinical trials and the related requirements of development. In the cases where the requirements for clinical trials and development programs have not been fully defined, or are dependent on the success of other trials, we cannot estimate trial completion or cost with any certainty. The actual spending on each trial during the year is also dependent on funding. We therefore direct your attention to Item 7 under the heading “Liquidity and Capital Resources.”
