Sunday, July 14, 2024 10:58:36 AM
exwannabe,
The issues with the ECAs in this trial are at least partially overcome by the clear effect on survival in rGBM patients. This is especially true in elderly patients who were generally given lower doses of chemo or removed from it completely because of intolerance to it. When this observation is taken into account all the other comparisons make
more sense, even in light of the fact that there is no patient level data which is at least partially due to comparative trial patients not having it available.
As to Flaskworks readiness I agree that the likelihood of early readiness is very remote considering the 18 month outlook given by Linda. On the other hand, the first GMP unit installation could be in months and approval of L using artisan will likely be within months. Marketing approval sets in motion the set aside reimbursement funding applications and immediate patient demand. There may even be a backlog from existing patient tumors that have been stored cryogenically. Sure would be nice to know when that starts to happen in earnest as that would be a hint that Dr. Ashkan believes that approval is within sight of creating an effective treatment before recurrence that will be accessible for his patients. Best wishes.
The issues with the ECAs in this trial are at least partially overcome by the clear effect on survival in rGBM patients. This is especially true in elderly patients who were generally given lower doses of chemo or removed from it completely because of intolerance to it. When this observation is taken into account all the other comparisons make
more sense, even in light of the fact that there is no patient level data which is at least partially due to comparative trial patients not having it available.
As to Flaskworks readiness I agree that the likelihood of early readiness is very remote considering the 18 month outlook given by Linda. On the other hand, the first GMP unit installation could be in months and approval of L using artisan will likely be within months. Marketing approval sets in motion the set aside reimbursement funding applications and immediate patient demand. There may even be a backlog from existing patient tumors that have been stored cryogenically. Sure would be nice to know when that starts to happen in earnest as that would be a hint that Dr. Ashkan believes that approval is within sight of creating an effective treatment before recurrence that will be accessible for his patients. Best wishes.
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