Timing and optionality. If we posit a BLA filing in 2H25 (calendar) the package may be approvable by mid-2026 assuming the process is expedited with Priority Review. Commerciality would therefore be drawn forward at least two years from where it sits in our model today (2028 approval). Figure 2 shows that we've already de-risked for TACTI-003-B but only ascribed a 52% p(success) to the accelerated approval event in mid-2026. After that, value development hinges on a confirmatory pivotal Phase Ill in 2H2028 and confirmation of market access milestones (principally pricing and reimbursement) approximately 18 months post-launch. As always with our real options-based valuations, value is ultimately driven by the underpinning market model, which as we've described, looks for US$450M peak sales.
IMM Price at posting:
24.5¢ Sentiment: Buy Disclosure: Held
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