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Zadie420

10/16/23 8:49 AM

#641197 RE: ATLnsider #641196

This is a great information. But I wish it would have come from company's update about their plan.
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Gus1212

10/16/23 9:05 AM

#641201 RE: ATLnsider #641196

So we are relying on the FDA to move our MHRA to other countries?
And close or during the holidays?
The Bright side of all of this (UGH) is that we will be able to load up on our Roth for 2024.

Then the FDA would forward the same DCVax-L submission application to any other Participating Orbis Partner (POP) country, who would also like to receive and review the DCVax-L application. These POP countries could include: Canada, Australia, Switzerland, Israel, etc.
Bullish
Bullish
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monentum2play

10/16/23 9:06 AM

#641202 RE: ATLnsider #641196

This is great info! Thanks
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martyDg

10/16/23 3:29 PM

#641359 RE: ATLnsider #641196

Until the day management say it. All of this are just mere SPECULATION. PERIOD.
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JMarv

10/16/23 6:14 PM

#641395 RE: ATLnsider #641196

Thanks for ATL great info!
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newman2021

10/16/23 7:45 PM

#641401 RE: ATLnsider #641196

wow a great finding and an info ATL is sharing with us. I didn't know before that one application to MHRA is good enough under the ORBIS program to be reviewed by RAs of other participating countries like US FDA. Hopefully this is it. If Orbis is the deal, absolutely it is a welcome delay that I would take it with both hands! Thanks ATL for sharing with us.
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fluteman

10/16/23 8:28 PM

#641406 RE: ATLnsider #641196

Wow!! Great contribution, ATL!
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ATLnsider

10/16/23 10:49 PM

#641419 RE: ATLnsider #641196

I want to clarify and correct 1 point I stated earlier about the Project Orbis program:

If NWBio’s DCVax submission application is selected by the MHRA to be in the Project Orbis program, the MHRA would notify the FDA and make a recommendation to the FDA, and then NWBio (not the MHRA) would also forward the DCVax-L submission application to the FDA, and to any of the other Participating Orbis Partner (POP) that NWBio would like to submit the DCVax-L application to.
Bullish
Bullish