Christine, Thomas and others from the Feelings thread. I have been following this stock for a while, although not closely. I'm sure you guys are aware that FDA approval of citicoline is not a slamdunk, although it may well happen. When IPIC published their results on the P3 trials I asked a couple of knowledgeable biotech investors for their responses to the release. Their answers are printed below. Just some more opinions for consideration.
>>All what I can say is be careful with IPIC and Citicoline. Drug didn't show difference in mortality rate and ischemic damage size, which I connect with severe disability. How will FDA look on this data I do not know. Also, IPIC disclosed news before full data analysis which is in connection with Redux problem.
I have some disagreement with Neuroinvestment on CNSI thread regards the IPIC.<<
Best regards,
mz<<
Regarding the IPIC citicoline results, along with MZ's excellent points I would add the following concern:
>>As a result of this imbalance and other statistical factors, the primary analysis of the study, the distribution of Barthel Index scores in citicoline vs. placebo-treated patients as a function of baseline NIH Stroke Scale scores, did not achieve statistical significance. However, this primary analysis was statistically invalid because the patient imbalance and other statistical factors failed to satisfy the requirements for the correct operation of the statistical model. Therefore, a protocol-defined responders analysis, percentage of patients who achieve a Barthel Index greater than or equal to 95, among patients with moderate to severe strokes, was employed<<
PIII results where they have to look for statistical significance in sub-populations make me very nervous (I hear some senior clinician on the advisory panel suggesting "further clinical studies"). Why didn't they identify this difference in activity before, especially if they have so much clinical data; IMO by PIII you should know your indication.
For what it's worth.
biowa<< |
