Monday, May 16, 2016 9:43:14 AM
"Leo receives case reports for each patient. On each report it should have the patient's name, age, sex, and whether the endpoints are met."
Except for the name, which according to a subsequent poster is actually a number (logical for privacy purposes), the fact that the company knows whether endpoints are being met (whether in real time or cumulatively) should allow it to assess the likelihood of success well ahead of the rest of us. My understanding of the "blinding" had led me to believe otherwise.
That fact, however, results in the company having to walk a very fine line when it comes to disclosure. I guess the way it plays out is if there's any notably bad news it needs to be disclosed but if the news can be perceived to be good it needs to be withheld. Lawyers....I guess they serve a purpose but it's not always obvious :o)
The Northwest Bio story is interesting but I think we have to note an important distinction:
"But investigators at MD Anderson and the two other hospitals conducting the DCVax-Direct study have not reviewed or analyzed data at all because patients are still being enrolled and treated. The statements being made by Northwest Bio about DCVax-Direct are derived from patient case report forms, which the hospitals are obliged to send to the company because it sponsored the study."
It sounds as if Dr. Aman Buzdar, vice president of clinical research at MD Anderson would have been less upset if Northwest had reserved their comments until the point at which CTIX is expected to be this week ("Once the blind is removed, data from each of the four arms of the trial (one placebo arm, three oral dosing regimens of Prurisol) will be reviewed and analyzed to evaluate the safety and efficacy of Prurisol.") EVEN IF NORTHWEST HAD THEN MADE THE SAME COMMENTS. His complaint centered around the procedure, not the comments themselves.
Even as a non-shareholder I'm fascinated by the prospects of this week's news and I think I'm beginning to understand the context it should be viewed in....thanks again.
"Successful commercialization is succeeding in the process of
commercializing. It is not successfully having commercialized."
Say what?
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