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Re: Lykiri post# 604400

Monday, 06/26/2023 12:18:54 AM

Monday, June 26, 2023 12:18:54 AM

Post# of 721739
Thanks Lykiri, yes interesting insights from someone who has considerable knowledge of the subject. Regional manufacturing is acceptable for now, but the matter of cryopreserving leukapheresis material will certainly be an issue (as I’ve repeatedly said) for Northwest Bio in the future, as the production numbers increase, or for global shipping to occur. (although the DCVax final product could still be shipped globally)

Despite what biosectinvestor says, your other post today is yet another confirmation that the current manufacturing process still uses fresh monocytes, since the patient (Tracy) was required to fly from Ireland to London to have the leukapheresis procedure performed.

And did you catch this part? Leukapheresis capacity is another bottleneck that many here probably didn’t realize, which could certainly limit the potential of any future large-scale tissue agnostic approval.

Based on internal Cryoport data, we conservatively anticipate clinical and commercial patients’ treatment cycle demand to exceed a minimum of 90,000 patients a quarter by the end of 2027. This dwarfs the current demand cycle of approximately 9,000 patients per quarter (as of Q1 2022). Moreover, based on discussion with physicians in the cell and gene therapy space, these numbers are further suppressed by the lack of accessibility to the collection and processing of blood products in community care centers – a significant latent opportunity for the market. Estimates suggest that the unaddressed opportunity in community care centers is around 80 percent of the overall patient opportunity. Consider that leukapheresis capacity is growing at a CAGR of around eight percent; this is expected to support only 13,000 patients a quarter by 2027.

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