"Kazia will work with its licensing partner to determine the way forward in China, given that country’s general requirement for local data to register a new pharmaceutical product".
IMO, management & the new Scientific Advisory Board should now focus on how a new Chinese GBM trial can be beneficial to both partners in the new licensing agreement.
Shareholders have invested in the strengths of paxalisib for its use in newly diagnosed unmethylated GBM patients.
Is it possible to negotiate a phase 3 Chinese trial, where only unmethylated GBM patients are screened and dosed with radiation therapy & paxalisib, against existing standard of care for GBM.
Simcere would fund and organize the Chinese regulations for the new trial, The number of patients to be recruited should not be a problem.
Kazia would supply paxalisib and maybe change the licencing to include other cancer patients, so as to avoid further Kazia shareholder funding dilution.
The data from this trial should address the 2/3 unmet patient treatment for newly diagnosed unmethylated GBM .
Meanwhile, the GBM AGILE study arm for paxalisib will be gathering valuable data from the (approximate) 150 patients with both newly diagnosed unmethylated GBM patients and recurrent GBM patients.
WIn, Win.
Regards.
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Ann: Kazia licenses paxalisib to Simcere in Greater China, page-113
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