Hi O&E@Odds&Evens
The old adage asks ... “how long is a piece of string?”
So, the answer is a tricky one. It will depend on many factors.
Some treatments gain approval before Phase 3.Note: Crizotinib received accelerated approval 3years after the first patient with EML-4/ALK NSCLC entered the phase I trial, and based on the results of a patient expansion cohort of the phase I trial and the confirmation of response rates and safety in a phase II trial.
The FDA’s Centre for Drug Evaluation and Research (CDER) approved 55 new drugs in 2023, and interestingly, if we break it down into therapeutic areas, we find that oncology gained the most approvals. Thirteen, or 24%, were new cancer therapies in 2023.
This should give the IMU team greater hope for either a regular approval or an accelerated approval (AA) in the nearer future. What year will that be? I don’t know. Possibly 2025, but more likely 2026/27. If Vaxinia continues to ‘smack’ all cancers though, then anything is possible.
Hi Ben @Watmighthavben
I agree, as you say ...
"some serious commercial rewiring of the business and commercial executives in the company needs to occur if all or any of these opportunities are to be brought to fruition"
In fact, I couldn't agree more. The scientists are certain doing their job, but we need to see a deal as soon as possible, and this responsibility sits with a different part of the IMU team.
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