AI
Friday, October 23, 2020 9:38:29 PM
Senti, I learned so much from your post. Of course you won me over at “examining… FDA Biological Products Guideline.” 
It’s great to gain insight into why the revised SAP is a superior plan and why having our sequence of a single primary endpoint and 5 secondary endpoints is strategic. This points to the genius of LP & team. I never knew how alpha was allocated in a clinical trial until 2 rereads of your post plus a splash of cold water.
And the climax, the FDA language/excerpts, explaining why the FDA may accept historical data in place of a control arm. More importantly why it is a perfect fit for our GBM trial (ie has a highly predictable death rate given current SOC).
No wonder the stock price has increased so much recently. The SAP is the waterloo moment for DCVAX's ultimate success IMHO.
It’s great to gain insight into why the revised SAP is a superior plan and why having our sequence of a single primary endpoint and 5 secondary endpoints is strategic. This points to the genius of LP & team. I never knew how alpha was allocated in a clinical trial until 2 rereads of your post plus a splash of cold water.
And the climax, the FDA language/excerpts, explaining why the FDA may accept historical data in place of a control arm. More importantly why it is a perfect fit for our GBM trial (ie has a highly predictable death rate given current SOC).
No wonder the stock price has increased so much recently. The SAP is the waterloo moment for DCVAX's ultimate success IMHO.
Invest in wisdom and compassion. The river will then flow.
