This is response to Andrew request on reply to my comment on IPIC and Citicoline.
Peter,
You should be careful before nameing any reply as *hasty reading* of the Citicoline interim data report . My experience from IPIC is 2 1/2 year long with closely company follow up to Redux FDA approval/debacle. When I learned about Redux limitation, Sibutramine (Meridia), and other drugs at FDA for NDA review for obesity, company misleading and manipulating of the investors sentimente by altering clinical data in press release (lying by one word) IPIC was dead for me. I had make profit in my investment on IPIC and I have closed my interest.
I advised Andrew with statement *be careful*! This are my expanded reasons:
1. Press release was disclosed at period when more true about Redux and its market share potentials were disclosed. It is released to bust investor confidence and sentiment, IMO. Some interim data was previously disclosed in Feb.
2. Interim data do not support big excitement about clinical outcome! Because data are short I will comment on data which are available. Excluding mild stroke group (who is responsible for this unbalance and for what reasons?) 84 patient in placebo group and 208 patient in Citicoline (What are distribution of the moderate , with only one point difference to mild stroke 8 to 7 by NIH scale, to severe stroke patients?, Are there any unbalance of this distribution which can negatively effect placebo group?, This group are reduced by ~35%!!!, What percentage of the patients for both group are analyzed by OC method?, ....) have moderate to severe stroke. Citicoline have positive outcome by OC analysis (12 weeks) method for Barthel score scale and 6-point Rankin scale but by LOCF analysis Citicoline do not pass. Why???? Is there again manipulation??!!! LOCF analysis is based on min. 8 weeks follow-up (six weeks of the therapy and two weeks, FDA ?, for first assessment) which give only 4 weeks for further follow-up. Not to long time difference for significant change in final data, IMO!!!
3. First PIII trials for 500 mg Citicoline treatment group show *limited* (p<0.04) significant results and some positive data for size of the ischemic damage but not in mortality rate. Some can be expected for data in this trial. Data from first PI (500 mg) was not suficient for NDA.
4. Data analysis are based on cognitive improvement/limiting the impairment which I name post-stroke or rehabilitation period. Very little can this drug help in first 48 hr where most of the stroke primary neuronal damage is done. Help and positive effects of the drug in patient with *mild*-moderate stroke is no question as drug is marketed in Europe and Japan. Also, Japan data can't significantly contribute to NDA because drug is administrated by i.v. infusion for shorter period. Also in Europe Citicoline is administrated for cognitive disorder in patients associated with several different disease condition. By this sale/market potential in US and Canada can't be linearly translated from Europe/Japan sale.
5. I am not questioning FDA approval of the Citicoline. IMO it will be approved but with label limitation. Also, I will be very careful to call this drug potential *blockbusters*. Instead, I will be cautious that it can share similar story as Redux did.
6. I will not comment on other IPIC programs as I do not have any interest for IPIC investment. The investment decision can't be based on Citicoline story alone, IMO, and my advice to Andrew was *be careful*. I am not for or against. I am not qualified for recommendation. But, I am positive on one thing: I do not trust IPIC top management and their press releases.
Good investment to all.
mz |
