Replies to post #138326 on Biotech Values

[turtlepower]

Are you of the expectation that just the announcement that they plan to file for accelerate approval, if that is indeed what they announce, will cause a jump in the share price or do you expect it would take an actual ultimate decision to move the stock?

I think if the EMA accepted the filing it would give investors some confidence in the PRECEDENT data and in a positive outcome in the PROCEED trial. I'm not sure whether the share price will jump significantly or not but right now the EV is close to zero so hopefully that will change in the positive direction after next tuesday.

Endocyte didn't publicly announce it until monday but it looks like they were granted orphan status in early february and while that in itself may not be a big deal the EMA appears to think that Endocyte has provide "sufficient information to show that this medicine may be of significant benefit for patients with ovarian cancer".

http://www.ema.europa.eu/docs/en_GB/document_library/Orphan_designation/2012/02/WC500123293.pdf
http://www.ema.europa.eu/docs/en_GB/document_library/Orphan_designation/2012/02/WC500123294.pdf

[Fuma102]

Cant imagine Endocyte gets approval for ovarian CA, if for no other reason than this:

http://investor.endocyte.com/releasedetail.cfm?ReleaseID=632710

No trend toward overall survival benefit in either trial arm. The PRECEDENT trial was not statistically powered to show a survival advantage and the results of the trial did not indicate a trend toward benefit in either arm (hazard ratio of 1.099 in the intent-to-treat population). While the median overall survival in the EC145 study arm of 14.1 months represented an improvement in relation to historical trials of PLD alone, the PRECEDENT trial PLD control arm had an unprecedented median overall survival of 16.9 months. These results may have been influenced by prognostic factors favoring the PLD control arm. Specifically, the level of sensitivity to post-trial platinum therapy as measured by platinum-free intervals may have been a factor. Patients in the PLD control arm received post trial platinum-based therapy at nearly twice the rate of those in the EC145 study arm, 33% versus 18% respectively. On an adjusted basis, which accounts for potential differences in demographics and prognostic factors such as platinum free intervals, the overall survival hazard ratio in the FR(++) group was 0.495, although the result was not statistically significant.
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tough sell with the control arm doing better than the test arm, no?