Drug lacks efficacy, so trial and data were mess up to altered that unwanted quality (scientific bias,very well research and proven effect, not talking willful conscious malice), not the other way around.
Who in their right mind will lose the x-rays, ct scans, documentations, calculations, mixed the subjects out of inclusion/exclusion criteria, the dead subjects (well, those ones were good to miss, it cleans the image of the drug) mistakes over months, with the corrections pointed to by the Watchdog, and risk $billions of market value and risk $billions of sales? Executives are all wanting, but idiots.
I do not buy the rush theory, some compared to Scios drug, but Scios drug was effective in a surrogate point and proven, sent back to prove (and they did) that the patient quality of life did improve (no improvement in survival proven and drug was approved). WAY different cases.
There is no evidence that the drug works, no need to wait for the foretold re-refusal of February 26, wait for H and N pIII confirmation of drug lack of efficacy and it will be already in single digits.
The patients need efficacious drugs, not acne producing failures.
Prove the drug, get approved, very simple! |
