Wednesday, May 18, 2022 9:23:16 PM
This is also a good time to remind those here that the results seen upon presentation at NYAS are an ADJUSTED comparison and that one of EXwan’s favorite criticism of the ECA database was that DCVax trial had a slightly less severe population as well as the comparisons made before NYAS were not apples to apples since DCVax data was from surgery where as the database was from randomization, thus favoring DCVax. The ADJUSTMENT fixed the imbalance by reducing DCVax raw data and the comparison to randomization now flips the favor towards placebo bc many of the patients in the ECA were randomized at 6 weeks vs 3.1 mo. Finally, the 3% IDH mutant rate in the DCVax trial is very low and likely much less than the unknown rate among the ECA and therefore also reduced true efficacy analysis.
Conclusion, the analysis is extremely conservative favoring ECA and FDA will or if you align with me HAS understood this in their evaluation of the data. It is not far fetched to believe FDA continues to show flexibility regarding the 11/22 speculation.
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