Hi @bavarian1975, I’m pretty sure someone from IMU has indicated the FDA has indicated the Ph2 patient numbers could be as few as 20 to obtain FDA marketing approval; and the FDA may allow some of the relevant Ph1b patients to be included the Ph2 numbers and data.
Also, I think the requirement for the durable responses was a minimum of 6 months.
So, it may happen quickly once the registrational trial commences. Potentially a submission for registration by the end of next year. I don’t know how long the FDA takes to review those submissions.
If IMU can gain FDA marketing approval then that would likely be a catalyst for BP interest, if it hadn’t occurred prior.
* p.s. Those comments could have been in relation to the Vaxinia expansion into Bile Duct cancer, so I’m possibly mixed up but don’t have time to double check. Regardless, at least one of pipeline could progress rapidly and may end up approved prior to any movement from a BP.
IMU Price at posting:
3.7¢ Sentiment: Buy Disclosure: Held
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