Friday, August 08, 2014 12:23:52 AM
I've been studying the stoppage rules and the data monitoring committee process
There is the process where by at a certain point the DMC determines that a drug works so well and is safe against the comparator that they recommend stopping the study and moving the comparator group to the new drug
Plenty of examples
When I studied those examples I determined the Pv-10 exceeds those requirements for stoppage by a long shot as long as the data is repeatable from prior studies
It is my opinion that about 50 patients in and about six months into the study that stoppage will happen
If so the DMC will recommend a stop and proceed to the nda
Pvct then will go to the FDA to see what they think
If the FDA agrees with the stoppage....and they usually go along with the DMC recommendation
Then the secondary endpoint of os will be rolled into the phase 4 post marketing
If so we are looking at about 3-4mm spent
Time line
Give another six weeks to complete the pIII protocols
It's going to be over 2000 pages just like the spa
Then give it 30 days more to be approved by the FDA
This puts us at mid October
It should only take 30 more days to start enrollment
Mid November
By May we should reach the point where a stoppage should occur
If it happens that will be the equivalent of a mid point interim analysis
Now let us back track to time of protocols being finished
I would expect mid October to send those protocols to India and china to consummate the regional deals
By then more sites will be open and ready
More money flows in to take the company to the end of pIII if need be
So if my viewpoint is correct
We are just one year delay for big Pharma
But wait
Timing is everything
That puts the company right smack in the middle of a pipeline crisis of big Pharma
The leverage will go to us
And some members of the boa are smaller than others
It puts us in a position of a dark horse riding in
Us being all of us shareholders and company
Big Pharma is fucked
We will be in the cat birds seat
Now there are those in NYC who are worn out and tired
They want to sell
Fine
If they do we trade them for new shareholders who will not have to wait that long
The early bird gets the worm
But the second mouse gets the cheese!
This has been the Vorlon Report
Buy sell hold at your own risk
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