Isotechnika Pharma Inc IPHAF

Some thoughts

[professional11]

1) The meeting was cancelled "to allow time for the resolution of several outstanding issues"
If the issues were un-resolvable, we would be discussing a rejection letter and not a cancelled meeting
2) The agency intends to continue evaluating the NDA - Good sign
3) The agency may schedule an advisory committee meeting in the future. - Good sign
4) The agency has not communicated all the outstanding issues to Lux - of course not.  That is the purpose of the action letter.
5) The action letter is expected approx Aug 3, 2010 - 6 weeks to wait.

Bottom line:  Several resolvable issues need to be taken care of.  The action letter will outline what these issues are. The FDA is keenly aware that 1000s of people are needlessly going blind every month this application is delayed.  For this reason, the agency may issue a letter of approval, despite the pending issues.

P11

[teevee]

Bottom line:  Several resolvable issues need to be taken care of.  The action letter will outline what these issues are. A resolution could delay an  approval into 2011 along with the European NDA. Cash on hand is only good until the 4th quarter.  Perhaps ISA could sell North American rights to Lux for a one time payment of  a few million dollars and hope to cash in

[bromley1877]

Professional, that doesn't make sense to me. surely they would not approve the drug in the face of unresolved issues even if they thought they could be resolved.  And even if they resolved them internally somehow, why would they now not need a meeting.They called a meeting because they felt they needed one before approval.  There may be rare cases where it is so clear cut they cancel

[ngerrits]

Thanks Professional11.So you are a buyer at the 0.20 to 0.25 range given the risks associated with the weeks events, possible delays, and remaining ISA cash flow?As you can see, many on this board are seeing too much risk for the very limited info available from ISA and FDA.  The survival of ISA and lux hang on this letter coming on or about Aug 3.10.I agree with you - people are going blind

[WASKERWISK]

bromley I think 'as needed" is a negative thing - they are saying the application may just be rejected in which case there will be no need for a meeting - the only positive i am seeing is that at this point at least they are leaving open the possibility of calling a meeting. So there is hope but it is hard not to be concerned.

[antoninus]

This eroding shareprice is disgusting.anyone else notice that 2 of lux' upper management guys were key players in the transplant field?

[frankandbeans]

Yes, its already been discussed.  Read back a couple days...Since we're all reading between the lines of the NR's, has anyone else noticed that it never actually mentions that the outstanding issues are related to the drug?  Is it not possible that they are administrative issues? Or production issues? Or that someone from the FDA has been reading this BB and realised that by