TNBC, they still need to enroll 2 (if not already)
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Posted On: 11/29/2019 9:19:24 AM
TNBC, they still need to enroll 2 (if not already) on 350mg, then wait. TNBC cost very little compared to mono.
From 2017 10k,
Our total estimated expenses for the Phase 2 GvHD trial are approximately $4 million. This is close to how much a month they are spending on the current mono trial.
The pivotal trial would be the huge cost. Without a deal or significantly or other funding, or a higher share price, that one would be the back-breaker. I would personally wait until higher price, funding, or approval (i.e. revenue). One reason for the high burn right now is they had to enroll another 200 patients in 2019 to satisfy the safety data for the BLA. 500 total patients on mono vs 3 on tnbc or 50 in gvhd; the current mono trial is responsible for the majority of the cash burn, which is needed for the BLA because of the FDA's safety data request.
From 2017 10k,
Our total estimated expenses for the Phase 2 GvHD trial are approximately $4 million. This is close to how much a month they are spending on the current mono trial.
The pivotal trial would be the huge cost. Without a deal or significantly or other funding, or a higher share price, that one would be the back-breaker. I would personally wait until higher price, funding, or approval (i.e. revenue). One reason for the high burn right now is they had to enroll another 200 patients in 2019 to satisfy the safety data for the BLA. 500 total patients on mono vs 3 on tnbc or 50 in gvhd; the current mono trial is responsible for the majority of the cash burn, which is needed for the BLA because of the FDA's safety data request.
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