DNDN after FDA decision on May 15

C

codedeep007

Let's cool down a little bit:

The FDA panel decision basically put DNDN at least in a position which has two very large successful Phase II trials and on-going Phase III trial. How much should it worth? I would give it at least 1B.

The current price might represent the following price matrix

Approval Letter $9 (50%)
Approved $27 (50%)
 
This is a fairly bearish report to say the least. Thanks for the info.
Big gap on the daily at $12.00 looks like it may be filled.
 

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All existing cancer trials are flawed, the long term survival rate should have the final say when it's available, period.

All clinical trials are using short term effects to predict long term results, they are often correct, but the long term result is what all clinical trials after.

Why VIOXX was pulled off the shelf? because the clinical trial could not establish long term effect of a drug.

The article uses "checkmated" as an example, but what if the referee found out that an important piece - the Queen was stolen in the middle of the game. Can we declare the dirty player as the winner?
NO.
 
The article mentioned:

26% vs 15% less serious patients in the treatment group.

OK OK, the difference is 11%, and we assume the extra 11% patients in the control arm ALL survived!!!!!!!!

DNDN still beats the 36 months survival rate by:

33% vs 26%(15%+11%)
 
Median Survival (month) Benefit is 4.5 months.

The Median Survival (month) is flawed, because nothing will change once half the patients died.
 
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