I return to the interim results. When Stamler first presented these interim results he compared them with the Wenning et al paper to find patients who had symptoms over 4 years. Now in his latest presentation, he does not make any comparison but only tells what happened in the 202 study to the patients.
This may be the right way because only the subjective scoring was common in the 202 and the Wenning paper.
Another possibility is to compare bioMUSE and 202 studies and the atrophy of the brain in them, even though the patients in the bioMuse study had symptoms for a much shorter time. The atrophy rate in the bioMuse study was a little over 4% /y and now Stamler says there was no additional atrophy during the latter half of the year in the 434 responders.
I think this is a concrete sign of efficacy in spite patient selection is different. I believe that brain atrophy goes on for many years unless an intervention such as 434 stops it.
Atrophy (volume) measurement is better than the iron content measure with 3T MRI. To separate iron from myelin you need a 7T MRI. When the patient improves, he needs to get his neurons myelinated and this remyelination can be interpreted in a 3T MRI picture as increased iron. Myelination needs iron.
A combination of volume change measures and symptom scores can be the best option in evaluating the efficacy.
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