HekaBio imeripoti kuwa matokeo ya awali ya jaribio hili ni ya kutia moyo sana, na kwamba itaendelea kukusanya na kuchambua data kwa kushirikiana na wataalam wake wa matibabu, katika juhudi za kuandaa wasilisho la kutafuta kibali cha uuzaji kupitia njia ya shonin kwa kushauriana na mamlaka ya Japan. . Hakuna matokeo ya jaribio la kimatibabu yanayotarajiwa kuchapishwa hadi yawasilishwe kwa mamlaka ya Japani.
Mkurugenzi Mtendaji wa Alpha Tau Uzi Sofer alisema, “Hii ni hatua muhimu kwa Alpha Tau, tunapotarajia kuleta tiba yetu ya kipekee ya Alpha DaRT kwa wagonjwa duniani kote. Baada ya kupata uidhinishaji wetu wa kwanza wa uuzaji nchini Israeli, tunatazamia kuona data muhimu ya majaribio kutoka Japani, tukiwa na lengo la kuanzisha jaribio muhimu nchini Marekani mwaka wa 2022. Japani ni soko muhimu kwa Alpha Tau, na tunathamini jitihada zisizochoka za Mkurugenzi Mtendaji wa HekaBio Rob Claar na timu yake, pamoja na wachunguzi wote kutoka vituo vikuu vya saratani nchini Japani ambao wameshiriki katika jaribio hili.
NINI CHA KUONDOA KATIKA MAKALA HII:
- Japan is an important market for Alpha Tau, and we appreciate the untiring efforts of HekaBio CEO Rob Claar and his team, as well as all of the investigators from leading cancer centers in Japan who have participated in this trial.
- HekaBio has reported that preliminary results of this trial are highly encouraging, and that it will continue compilation and analysis of the data in collaboration with its medical experts, in an effort to prepare a submission seeking marketing approval via the shonin pathway in consultation with Japanese authorities.
- Having secured our first marketing authorization in Israel, we look forward to seeing pivotal trial data from Japan, with an eye toward initiating a pivotal trial in the U.
