I definitely do not think they are incompetent. There is always the possibility that there are other factors, including regulatory factors, slowing or delaying their process. This trial, more than most is affected by legacy regulations and new regulations. There are numerous layers of regulation at which this is apparent.
From the assembly of not just the trial data to the external historical data, to the analysis using historical data, to the inclusion in such programs as we are discussing today, not the least of which is Project Orbis. There are just layers of things in the process of change for the better and these kinds id pending, yet delayed reforms can cause necessary delays. Even the condition, GBM is being redefined simultaneously.
I do not believe the regulators want any of this to undermine an approvable drug, but they may require an advisedly careful and systemic approach to revealing any information and toward the approval process.
Market Data 
Markets 
AI
