Thanks
@unbelievable and others.
"
... less of the cringeworthy empty dribble that offers nothing." Exactly the content I don't like. Conjecture is fun and easy - that's why there's a lot of it. Even I do it sometimes ... in my head! I understand everyone here wants to make profit out of this as do I but I'd like to see some a balance of analysis on the financial, commercial and research elements of this stock.
The HER-Vaxx preliminary data is great but it's yet to be seen whether it's perceived as superior than other approved drugs such as Keytruda and Herceptin. The magnitude of survival effect has clearly been demonstrated in the Phase 3 study using the Keytruda + chemotherapy combination therapy given the substantial sample size. With time, I'm hoping we should see even a wider magnitude of survival benefit from HER-Vaxx Phase 2 study with a slightly increased sample size. I'm sure everyone would be thrilled if the median OS of 14.2 months was even longer when the Phase 2 final results are published!
As
@Winsolo pointed out, the good news is that the IDMC have provided reassuring guidance. I believe the ethical justification for reducing the sample size is that the control group (chemotherapy) would risk not receiving the potentially added survival benefit of receiving HER-Vaxx. My opinion is that it's double-edged here: (1) the reduced sample size potentially means that there's less time-to-event required to wait and we may hear news about the final results earlier; but (2) Imugene and us continue to wait to see if the results can hold and remain statistically significant based on the sample of ~34 patients. I don't want to get stuck on the point of the sample size as, after all, this is a Phase 2 study and it's likely to not have the optimal sample.
For what it's worth, I'm super interested on seeing how CF33 (Vaxinia) goes which will take years. I don't think I've seen any novel cancer development use a poxvirus. If I recall correctly, Viralytics re-engineered the common cold and T-VEC uses a herpes simplex virus. It will exciting to see how CF33 goes!
(20min delay)