I thought this makes a lot of sense read it! burnaka • 1 hour 28 minutes ago
12users liked this postsusers disliked this posts0Reply
This is the rebuttal I posted to the AF article, stating facts to bash his article, and an opinion or two
nor has the company explained how or why FDA will be copacetic with a primary endpoint of progression-free survival. "
I find it hard to believe the FDA would give the GO AHEAD for a study but allow the study with an invalid end point. Guidelines from FDA 2007 regarding trials :
Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics"
Quote: "TTP and PFS have served as primary endpoints for drug approval. TTP is defined as the time from randomization until objective tumor progression; TTP does not include deaths. PFS is defined as the time from randomization until objective tumor progression or death. The precise definition of tumor progression is important and should be carefully detailed in the protocol. "
Apparently this quote from the FDA from the trial end points section was missed by the author. PFS is INDEED a valid endpoint.
As far as missing data, or lost data? Really ? That data is considered sacred, it is not lost or missing. Making that type of ASSUMPTION is beyond funny.
The safety data is ALWAYS looked at first Adam, ALWAYS, the data interpretation beyond that can take up to six months before it is DEEMED late, but you do not keep enrolling patients if there is a safety issue.
As far as NWBO responding to investor inquiries it might be that the INVESTOR RELATIONS number was posted on the yahoo message board yesterday, and they had countless calls. They opted to give the partial info that they had in response to this rash of calls, The DATA may take 6-8 more weeks and still be considered timely. DMC's can take up to 6 months before it is considered late. Less
Sort: Newest | Oldest | Most Replied Collapse all replies
burnaka • 43 minutes ago Flag
3users liked this postsusers disliked this posts0Reply
In a second post to AF I wrote:
To get an SPA in a phase 3 study it has to be before the start of the study, and before one patient is enrolled. NWBO phase 3 was not entitled to be granted SPA because it was a continuation of an on going study. The author should be aware of these basic FDA standards if he writing on this space. He tries using NO SPA, and PFS to hammer NWBO when in fact PFS is INDEED an accepted end point, and NWBO was never entitled to an SPA. Info he either did not know or chose to omit, the former explains why I find his articles manipulative and lacking validity. Less
