Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Yes and no.

$ELTP could use the same two month 150 to 200 persons P3 Bunionectomy trial for their 12 Hr ER Oxy/Nal trial vs Comparators Roxicodone and Revia. There is no need to wait for ALO-02 for which no PDUFA date has been set.

I definitely agree that at some point in the very near future it would not be worth waiting for ALO-02 before proceeding with Plan B. I think it is reasonable to give a goodly few weeks after a presumably favorable AdComm before giving up hope.

I disagree that the same kind of study could be conducted. ER/LA formulation used for moderate-severe chronic pain could not use an acute pain bunionectomy trial. May not have to be any bigger, but definitely would be more involved and longer time duration. With ELI-200, every participant was in & out in one week. Very easy to recruit as you go. For ER/LA formulation, any efficacy trial would follow each participant over multiple weeks. ALO-02 had study with n=400 and 6 weeks titration followed by 12 weeks of study. We would not need 400 but the design would be similar. Basically all participants have to be recruited before starting, so the first dose date would be months out.

Everybody with a vested interested in ELTP should be rooting hard for Pfizer this week. ALO-02 approval is crucially important for many reasons.


http://press.pfizer.com/press-release/alo-02-demonstrates-significant-difference-pain-scores-chronic-low-back-pain-patients-