Ken: Based upon the milestone dates you cited for Zongertinib, I see the evolving FDA approval goal posts moving more beneficially in LL's direction.
From November 29, 2024, when Zongertinib's Phase 1b data showed a truly compelling ORR of 71% in a pre treated cohort (N about 70) of lung cancer patients, accelerated approval was granted for Zongertinib on August 8, 2025 as a second line treatment. That's just over 8 months from compelling ORR data in a small patient population to accelerated approval as a second line treatment.
But then it gets better. The FDA issues one of Dr Makary's National Priority Vouchers to Zongertinib, whereupon its manufacturer, Boehringer Ingelheim, then files for accelerated approval for 1st line treatment, and that gets granted in 44 days on February 26.
So I'm guessing that if LL can post a > 70% ORR from interim CRC trial data, and considering that treating CRC would have to qualify as a national priority, receiving a National Priority Voucher, as per Zongertinib, would appear possible. If so, could accelerated approval not be far behind based on the same ORR and DOR metrics used as surrogate endpoints by the FDA for Zongertinib?
The key factors in the above scenario would be the >70% ORR and the filing of a BLA, neither of which obviously can be considered a given even if the earliest CRC trial data was very promising. And the way in which a "response" is defined in the protocol would also be critical. But if CYDY were to announce that Zongertinib benchmark of a >70 ORR sometime in the next several months and a BLA could be prepared in that time by Syneos Health (our CRO for the CRC trial), well -- talk about "open waters"!
From November 29, 2024, when Zongertinib's Phase 1b data showed a truly compelling ORR of 71% in a pre treated cohort (N about 70) of lung cancer patients, accelerated approval was granted for Zongertinib on August 8, 2025 as a second line treatment. That's just over 8 months from compelling ORR data in a small patient population to accelerated approval as a second line treatment.
But then it gets better. The FDA issues one of Dr Makary's National Priority Vouchers to Zongertinib, whereupon its manufacturer, Boehringer Ingelheim, then files for accelerated approval for 1st line treatment, and that gets granted in 44 days on February 26.
So I'm guessing that if LL can post a > 70% ORR from interim CRC trial data, and considering that treating CRC would have to qualify as a national priority, receiving a National Priority Voucher, as per Zongertinib, would appear possible. If so, could accelerated approval not be far behind based on the same ORR and DOR metrics used as surrogate endpoints by the FDA for Zongertinib?
The key factors in the above scenario would be the >70% ORR and the filing of a BLA, neither of which obviously can be considered a given even if the earliest CRC trial data was very promising. And the way in which a "response" is defined in the protocol would also be critical. But if CYDY were to announce that Zongertinib benchmark of a >70 ORR sometime in the next several months and a BLA could be prepared in that time by Syneos Health (our CRO for the CRC trial), well -- talk about "open waters"!
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