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aesop1

07/12/23 11:29 PM

#609173 RE: ATLnsider #609170

You do know nwbo has yet to submit so the jury is out. These other companies have submitted and have pdufa dates. Don't count your chickens, there ain't even an egg yet. Or are you stilll speculating they are submitting simultaneously under orbis??
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flipper44

07/13/23 1:03 AM

#609189 RE: ATLnsider #609170

Started, at least, back in Germany, as I recall.
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flipper44

07/13/23 7:31 AM

#609217 RE: ATLnsider #609170

ATL, I just need to reemphasize what an excellent post/response/reminder this is. I’d give it many more than one like if I could.
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CrashOverride

07/13/23 9:23 AM

#609240 RE: ATLnsider #609170

Still my favorite ASCO presentation by Bosch.
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dstock07734

07/13/23 12:26 PM

#609341 RE: ATLnsider #609170

ATL,

Great post!

In Dr. Bosch's presentation in June, he mentioned dozens of patients with various cancers receiving DCVax-L through compassionate use. I suspect for a patient eligible for compassionate use, he/she must have metastasized cancer and SOC must have failed. Does this mean that DCVax-L can do a job for inoperable tumors like Direct? If DCVax-L can, it means in the future if DCVax-L is approved, no need to remove healthy tissues surrounding the tumor as required by the current SOC. What's your take on this?

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flipper44

07/13/23 3:49 PM

#609429 RE: ATLnsider #609170

Could someone sticky ATL’s post? 609170
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joeycav11

07/14/23 2:28 AM

#609590 RE: ATLnsider #609170

It cost mesoblast over 2 years so far as the method of action and assay results were cited to deny approvoal. Even though meso had outstanding results and a 9 to 1 vote to approve ryoncil.
I believe meso will get the thumbs up this time on the resubmission pdufa date aug 2 .
The cell therapy blows away the competition without side effects... Sound familiar...