I-HekaBio inike ingxelo yokuba iziphumo zokuqala zolu vavanyo zikhuthaza kakhulu, kwaye iya kuqhubeka nokuqulunqwa kunye nohlalutyo lwedatha ngokubambisana neengcali zayo zonyango, kumzamo wokulungiselela isingeniso esifuna imvume yokuthengisa nge-shonin pathway ngokubonisana nabasemagunyeni baseJapan. . Akukho ziphumo zolingo lwezonyango ekulindeleke ukuba zipapashwe de zingeniswe kwabasemagunyeni baseJapan.
Ingqonyela yakwa-Alpha Tau u-Uzi Sofer uthe, “Eli linyathelo elibalulekileyo ku-Alpha Tau, njengoko sijonge ukuzisa unyango lwethu olulodwa lwe-Alpha DaRT kwizigulana kwihlabathi jikelele. Emva kokuba sikhusele isigunyaziso sethu sokuqala sokuthengisa kwaSirayeli, sijonge phambili ekuboneni idatha yolingo olubalulekileyo oluvela eJapan, ngeliso elijonge ukuqalisa ulingo olubalulekileyo e-US ngo-2022. IJapan yimarike ebalulekileyo ka-Alpha Tau, kwaye siyayibulela imizamo engadinwayo I-CEO yeHekaBio uRob Claar kunye neqela lakhe, kunye nabo bonke abaphandi abavela kumaziko omhlaza aphambili eJapan abathathe inxaxheba kolu lingo. "
INTO ONOKUYITHATHA KWELI NQAKU:
- 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.
