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kabunushi

12/16/22 9:40 PM

#549965 RE: DewDiligence #549934

For 131I-omburtamab, Serious Adverse Events (“SAE”) was found in 40.6% of the patients and were mostly related to myelosuppression.

Dc-vax-l is unquestionably safe. Do some more Dew Diligence before making nonsense comparisons.
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biosectinvestor

12/16/22 9:45 PM

#549966 RE: DewDiligence #549934

There were also other reasons for that decision besides the terrible side effects. It was run only at Memorial Sloan Kettering (MSK) and it was perceived that they moved heaven and earth to give the patients in the trial better care than other patients, there was no randomization as there was with DCVax-L even if the placebo patients crossed over. DCVax-L was in a global trial where patients and doctors from numerous institutions were involved and none of the doctors was unblinded.

Those doctors were independent, and the drug you reference was an MSK related effort. The likelihood that MSK was giving patients for their own drug in their own trial a lot of extra effort to ensure they had the better results, plus it was not unblinded… made the results less than reliable. And I think there were specific instances of beyond normal efforts, I could be wrong but I basically remember it being a single trial center effort for their own drug being a major issue.

So a lot of factors that might have helped make the results more believable were simply not there, that were there for DCVax-L, besides the incredible effort to really ensure that the ECA was well crafted and included a large number of patients, multiples of what were in the actual trial.

Plus it has terrible side effects.

I also suspect the MHRA has not made it possible for this other MSK effort to sell their drug in the UK before approval through any special programs nor was it designated and promising innovative medicine by the MHRA, like DCVax-L was designated.
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flipper44

12/16/22 11:21 PM

#549981 RE: DewDiligence #549934

While anyone here should agree not all risk is eliminated from the approval process for DCVax-l, the Omburtumab rejection comparison you found is well off the mark.

For starters, regarding Omburtamab, the agency said that it could not be ascertained that the patients in the external control group selected for reference by the company, had a similar underlying prognosis as those treated with Omblastys in the study.




Whereas, GBM has an extremely well understood underlying prognosis.

That’s just one point. There are so many more factors beyond just that boding well for the DCVax-l data. Have a nice Friday evening.