Replies to post #143703 on Elite Pharmaceuticals Inc (ELTP)

[dr_lowenstein]

yes that is correct. but tell us how many 505b2 are approved without applicant sponsored efficacy data, and more relevant, any combination products approves without applicant sponsored efficacy data. thanks

[tangerine]

Exactly Hike. Adding inactive beads that are proven to pass through the body would certainly qualify. What would you possibly test anyway in an efficacy trial that you didn't already know? Opioids have relieved pain and been on the market forever. Elite already makes generic opioids.

FDA had never seen anything like ELite's product before....until possibly this Zohydro situation

That is why the leading 505B2 company in Camargo and Elite in discussions with the FDA have given the recent timeline and that current plans to launch in 2015 should not be impacted. The company has been several steps ahead of investors for awhile now. I expect the next information to be that they are done with whatever else the FDA would have liked to see.

Based on the trading and misleading Hotstocked articles, it is clear that the manipulators behind these items certainly wouldn't want folks thinking about this.