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frrol

09/28/21 10:05 AM

#331328 RE: TC65 #331319

The net endpoint changes were:

1. CGI-I changed from primary to secondary
2. Incidence of AEs changed from secondary to primary
3. RTT CIA added as new secondary
4. CHQ added as new secondary
5. Plasma concentrations monitoring as new other
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TempePhil

09/28/21 10:22 AM

#331332 RE: TC65 #331319

TC, the delay is a function of only having 4 trial sites, to get 84 patients. Compare that to the number of sites for Avatar and the avatar patient count, or the alz trial.

The delay was predicted.

The questions are...
How much does it cost to open trial sites?
How many years worth of cash is Ana sitting on?
How long has Ana had enough cash to fund additional sites?
What are the priorities for assigning this cash?
Who allocates this cash to projects?
How much will this Rett delay affect revenue?
What is the cost/benefit analysis for this revenue versus trial site cost?
Why is this critical Rett program Excellence not seen as a HIGH priority?

This is an example of how Ana has redefined the meaning of SOON!!

These are questions upper management should be dealing with!