ATLnsider, basically yes, I would be pleasantly shocked to see that they are now applying for a tissue agnostic cancer therapy approval as opposed to setting the stage for it in short order.
While I think their safety profile will enable this in rapid fashion in the future, and their MOA theoretically demonstrates it may apply to all solid tumors, their body of data is insufficient to prove better than current SOC therapies across the board. While I do not think it is impossible I think it is a remote possibility due to the scarcity of data that I am aware of. I guarantee when Merck achieved their tissue agnostic approval the application was full of supportive studies, multiple confirmatory studies across multiple cancers and a plethora of publications supporting the theory of Keytruda's MOA. I don't think I am being negative, just realistic.
If NWBO achieves an MAA which includes FW to support GBM I will be elated because I think parlaying that into a platform for all solid tumors will be a direct and time efficient possibility for an experienced pharma partner to help them do. I will be fine to be pleasantly shocked if it occurs but I am planning on GBM with FW initially and a development platform to come for all solid tumors.
A while ago I spoke about data and development plans to determine length of investment hold post GBM approval. Now we are more enlightened about the GBM data, much of which can be utilized across solid cancers theoretically. This is the first real enlightenment of their development plans, which I think is a significant revelation.
If they can just attain MHRA approval for GBM with FW in the filing, and, get their finances on track, this will be an amazing story. As I have also stated I am hoping for a major BP partner in the near future to help them take this onward and upward, all just my opinions.
ATLnsider, your posts are wonderful, thx.
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