Isotechnika Pharma Inc IPHAF

some thoughts

[professional11]

The FDA did work closely with Lux.  The trials were designed properly.  Unfortunately one of the end points wasnt reached because of non-drug-related dropouts.  Thus, the FDA has asked for them to re-do the trial such that they can acheive the endpoints that they (together) agreed upon.

Next revenue milestone is EMEA approval in Feb 2011. ISA is cash poor, it will need cash to stay afloat.  Where is the cash going to come from?  People have mentioned LUX, Paladin, angel investors, and a takeover.  I would also like to think that ISA has been in touch with the govt of Alberta.

P11

[macbethorfaust]

Thanks for you thoughts Professional but it would also have been known to the FDA way back in March of 2009 that not all the endpoints had been achieved – now, maybe FDA led them to believe that as they were only looking for the posterior indication that it would not matter and then varied their position but I think what really happened here is that there were some aspects of the study that upon a

[labumba]

If this is the case, FDA has been refering to the second trial as below :  " In study LX211-02 the 0.4 mg/kg BID dose showed a reduction by 50% vs. placebo in rate of recurrence of inflammation at 6 months using a pre-specified analysis that accounted for data censoring due to non-efficacy-related discontinuations. The study did not meet the primary analysis endpoint of all-cause

[BornReady1970]

I can't speak for other Albertans, but I for one would have issue with the gov making loans to private business, and weak ones at that. Even if they would, do you truly think it'll happen in under four months?

[labumba]

I mean " in the pool of second trial  ( LX211-01 ) " should be ( LX211-02 )