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hope4patients

08/29/22 5:20 PM

#509137 RE: dennisdave #509130

Hahaha this is comical.
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biosectinvestor

08/29/22 5:56 PM

#509159 RE: dennisdave #509130

So you honestly think that after MHRA approval, the next approval would not come for 2 years and it would be only the EMA? That is a very unrealistic set of assumptions I think.

If MHRA approves, expect there to be other approvals even potentially beyond the UK given the commonwealth agreements. Also, expect there to be Canada at the least, shortly after, a former commonwealth nation, and then I expect the US at least and likely the EMA as well. I won’t give an estimate on timing, but definitely not 2 years later.
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ATLnsider

08/29/22 6:01 PM

#509160 RE: dennisdave #509130

You are free to believe what you believe. I will agree to disagree. I do not expect what you are expecting. In fact, my estimate is that NWBio will have all of the regulatory approvals for DCVax-L, including: UK, US, Canada, Germany and the rest of the EU no later than the end of 2024.

Also, in my personal opinion, those DCVax-L regulatory approvals are a foregone conclusion. It's pretty much "a done deal". My focus has pivoted, shifted and moved on to the following:

(1) When will NWBio obtain regulatory approvals for DCVax-L in the rest of the world (ROW), for DCVax-L to treat ndGBM and rGBM patients globally,

(2) When will NWBio expand the DCVax-L label to obtain worldwide regulatory approvals to include treating all or most other operable solid tumor cancer patients around the world.

(3) When will NWBion obtain worldwide regulatory approvals for DCVax Direct to include treating all or most inoperable solid tumor cancer patients around the world

(4) When will NWBio either be acquired or partner with a large pharmaceutical company to help maximize resources, including a sizable injection of the cash needed to fully exploit the worldwide expansion of both the DCVax-L and DCVax Direct vaccine platforms to treat all or most solid tumor cancers, alone and/or in combination with other approved treatments.