Why people worry.....expectations did not match reality, bashers instilling doubt and fear, not being comfortable with understanding the process, the drug, and the influences.....and all of this is reflected in the share price.
Why I am not worrying....I understand what happened and why....I dismiss the bashers because their overt agenda (though from time to time they made valid points worth investigating), I have spent enough time to earn a PhD in understanding the drug and the drug approval process. I am not always right but when I am wrong I try to understand why. So far I have seen the past and understand the path forward. There were detours and obstacles unforeseen but now I see an open meadow and a straight path forward.
Confidence is derived from educating yourself and developing an understanding of the big picture.
Areas to familiarize yourself in:
How pv-10 works
The other drugs and how they work
The response rates associated with the all the drugs
The approval process....AA, BTD, and the standard PIII
The endpoints in each process
The DMC....data monitoring committee and it's responsibilities
The route to the NDA
Reading all the data and reports from all the independent doctors and hospitals involved....seeing Dr. Weber change his opinion to being one of the biggest proponents of PV-10 is a big eye opener.
Understanding why it took years to get to the BTD application
Understanding what the FDA was doing to them on PIII/SPA endpoints during that time
Why the FDA rejected the BTD and why it does not matter because the way forward now will take about the same amount of time to get to the NDA as the BTD would have....IMO.
With educating yourself you either become more confident or less.
I for one have become more.....but confidence does not mean certainty and we yet may see the path twist and turn some more.
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