Replies to post #153893 on Elite Pharmaceuticals Inc (ELTP)

[Couch]

Agree. A slow creeping feeling of wariness is growing in me. Strong language of inevitability, the 'Nothing can stop us' quote, has been dissolving via delays into something more akin to praying something happens.

The FDA gives Elite their guidance and tells them they have to do 3 more studies before Elite can file their Eli 200 NDA. Looks to me like Elite has now finished 2/3. Now why would the FDA give Elite its guidance for a Phase III trial if the FDA was going to stop Elite? And Elite files their Phase III trial on the clinical government site. Should Elite not dose that first patient by the next CC. That is when I'll begin to worry.

Elite also announced that dosing was completed for two studies to support ELI-200 product labeling - the fed study and the withdrawal effects study. The first study is a Phase I, open-label, randomized, single-dose, three-way crossover study to compare the bioavailability of ELI-200 to the reference product under fed conditions in healthy volunteers. The second study, a safety study, is a randomized, double-blind, multiple-dose, parallel group study to evaluate the potential withdrawal effects following administration of ELI-200 versus the reference product in methadone-maintained opioid-dependent subjects. Final study results are not yet available.

However, our primary focus is still ELI-200. We cannot lose sight of that. As far as ELI-200 is concerned, we have a solid formulation; we have made the regulator batches, registration batches as per FDA requirement. We have them on six month stability and accelerated stability and 12 month controlled room temperature stability. The results are excellent. We have had a successful BE, we have had successful category one in vitro analysis completed. We've had a successful category two, which is Pharmacokinetic study completed and report is filed.

We've had a successful HAL study, human abuse liability study, completed and was very successful. If you recall from previous presentations where people actually crushed and snorted the brand versus our product; they knew when they took the brand that they got high, 92% of the patients that crushed and snorted our product thought they were taking a placebo. These are outstanding results. We've submitted and had a protocol for a pediatric study, which will be initiated a year or so after we launch the product and we are ready to file. We met with FDA and FDA added three requirements, which you saw in our press release. Two of the three FDA made it very clear that they are for labeling purposes only.