Issues in trial design that will complicate approval (crossover). Issues with pseduo progression that will complicate PFS showing a benefit over the control group (i.e., treatment works but cannot be approved under the current trial). There are just too many arrows pointing in the direction of something being really f'd up. The clincher though is LP selling tens of millions of shares for pennies. That would never happen if they had something of substantial value on the brink of success.
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