To think Elite is done paying lawyers regarding any potential litigitation is pure foolishness. Just because they have done some prep work doesn't mean they are done or even remotely close. I have seen the costs of small, medium and large cases. This isn't even remotely close to being done being paid if litigation is pursued. Not even close.

The litigation comes at a high price for a cash strapped company such as Elite. Upon SequestOx approval we do get the $7.5M from Epic, however would be sad to see it used towards litigation. Let's just hope it only gets dragged out months instead of years.

I do recall the insights you have shared regarding the hot melt extrusion process and the limitations. While the FDA knows this already I don't see how they could have approved Troxyca unless the stability issues were resolved. It is exactly why Embeda was initially pulled. They wouldn't want to go through the same embarrassment and allow any attempt to tarnish their reputation.

I am the same way on odd # shares. Ha! Last I bought was back at 0.135 a month or so ago. My order this morning is close to complete.

Decided to buy a little more on drop, but not nearly as much as I wanted. We'll see if rest executes.

I do find it very bizarre that Troxyca has not launched yet.

Thanks for your post from earlier today. Very enlightening regarding the solution vs tablet comparability.

No remember we don't get full rev. We get margin on mfg & % split on rev that has not yet been divulged.

You are exactly right. It is this confusion that I feel doesn't pave a solid path for oral labeling both by a 3rd party panel or internally at the FDA. I could be completely wrong, but I think it easily leaves the door open for the FDA to deny labeling here.

Where have you seen that? Please explain why on Earth companies are trying to refine tech to defeat overdose by swallowing via ADT?

Odds of approval may be higher now (once we know more about next requirements). I also think we have a good chance of getting ADT labeling for snort & injection. I honestly don't even think we have the remotest chance for oral labeling. We can avoid chewing, but not simply swallowing.

I think the perfect solution the FDA is looking for will have a combination of physical & chemical ADT characteristics to get around all the nuances. I could be wrong, but to get a high from Elite's SequestOx, one only needs to swallow more pills. No need to crush, snort, inject. It is even simpler - just take with water.

Pricing of orphan drugs was attacked by both media and Congress in '16. High pricing has killed some drugs in the past. Hoping Nasrat plays this critical card right. One can demand a premium for unique tech, but the company cannot let greed dictate pricing.

Very well thought out & worded. Thank you for bringing the board back to earth. This article has been misinterpreted so much that it is become easy fodder for the naysayers. I look forward to hearing of your other thoughts regarding "the cake". Thanks for the post.

I would agree. If insiders didn't sell at 0.97 (where there was minuscule volume anyway) they certainly aren't selling at $1.00. The ball is in Elite's court. The potential exists to go much higher, but the real & big question is whether this management is going to deliver - a single, double, homerun or grand slam. That has yet to be determined. They've made some fumbles and they acknowledge that. I like the way Nasrat thinks, but not sure we have his full undivided attention with his Mikah side business.

Yep, I get that, but putting a date down when the CEO didn't is just brilliant, don't you think?

Creating false expectations. Nasrat stated by the end of January. Nice try though.

You are spot on. If/when SequestOx does get approved we will get the manufacturing profit, but also an additional small % split. 2017 will be make or break for the company. Other tech is being developed fast.

I didn't say Elite was a junk stock. I am pushing for realistic expectations on timing of next steps. The ball is in Elite's court and will be interesting to see if management can deliver in 2017 or 2018. If they can defeat the odds, the potential returns will be monumental.

I assume you also read the disclaimer at the beginning of the deck:

This presentation reflects the views of the speaker and do not reflect official FDA, HHS, or other government opinion or policy.

To your comment, some people will see what they want to see. To the detail-oriented there is much more.

Not at all, they are those that don't ignore critical data and that can differentiate the two. Best of luck.

I could also point out data flaws that I noticed in this deck after 2 minutes of reading that lead me to be concerned over the data integrity of the presentation.

These aren't the exceptions. Welcome to the wonderful world of the FDA. Too many inexperienced traders read into posts that are entirely optimistic and create unrealistic hopes. This is reality.

Don't overlook the footnote:

**Performance goals in the chart means FDA should take an action on a certain percent of applications, etc. within the timeframes listed; it does not mean FDA should approve applications, etc. within such timeframes.

An actual approval may require a series of application adjustments and amendments dragging this out far beyond 2017.

For example in how fast the FDA moves, how many years have we been waiting for simple site transfers?

There is a path forward, but we have no idea what that means. Could be one or multiple trials.

I like the CEO. He hasn't been perfect, but he has done as well as anyone could despite the initial cards dealt. It is not uncommon for Sr team members at large organizations to run smaller companies, especially startups or companies in need of turnaround efforts.

Sadly, this doesn't signal anything. This is often the case with penny stock biotech/pharma. If they sell, the retail seller follows plummeting any remaining value.

You know very well how FDA minutes work. Agreement needs to take place between Elite & FDA on what was both discussed and agreed upon. Nothing new here and you know it.

Wow! Unbelievably sad regarding the lengths people will go to for profit. Absolutely disgusting. I was worried about Fentanyl craze as Elite's tech can do nothing to stop it and not sure what tech could. Hopefully shutting down the pill mills will resolve the issue.

Come on. You think the company will prepare, complete, analyze, write up, fix NDA, submit
& have it reviewed and approved by the FDA in that timeframe? Pure BS. We'll know more in a month, but depending on the study 2017 approval may not be realistic.

I would completely agree with your timing. Approval could happen in 2017 if everything falls into place and unknowns are non-events. With how long it took to get the CRL review I don't think we have are labeled as a Class 1, but just my impression. We will know more soon enough.

Merry Christmas all!

Not a soft bash. We simply have zero insight into the timeframe. Hopefully just weeks away for resubmission vs months. When you step back & understand that it took 6 months to even meet with the FDA you realize how slowly things really move. Retail investors are expecting speedboat to type moves from the titanic.

The minutes and action items must be agreed upon by both parties. Leave it up to the government to add red tape. In any normal business meeting this is done before the meeting concludes. Absolutely ridiculous if you ask me.

It was expected that this review meeting wasn't going to take 6 months to take place. Sad, but true. You need to ignore fake news mentioned here that they are on phone with FDA, meeting with the Elite the weekend after NDA rejection, etc. These are just ploys to minimize their portfolio damage.

I bought more last week under 0.14 and thought about selling on yesterday's predictable second morning spike. I share your same concern that the news was overhyped. Nasrat provided hype pre-FDA minute release. My interpretation of this is that it is to push against last minute tax loss selling pressure and/or additional dilution for needed studies. Great to hear meeting wasn't positive, but not holding my breath until we have more details about cost & duration required for resubmission. For all we know we might be 2 years away. It is a significant unknown and failure to realize this is a critical error. In the end, I held the shares until we know more in a month's time. No reason to break out the bubbly quite yet, but we may be getting close.

My interpretation of the process is that the $2.3M waiver could have been applied for post-submission. I don't recall offhand how tight cash was, but in the end it was only a 6-week or so delay.

Interesting thought.

I won't get too excited until we hear more at the end of January. My guess is the FDA ok'd or tweaked one of their proposed studies. We have no idea on duration of study at all - will it take a few weeks, several months, etc. I am curious as to what is still remaining for them to prove out. Regardless, it will be fantastic to jump this final hurdle to get this pipeline really cooking. More to come in 4 weeks.

Was pondering selling all shares a couple months back from all my portfolios. Stepped away for a while and thought the risk of holding continued to be pretty good. Added more recently at 0.1365.

I would expect next week to be rather volatile due to lower volume and last week to sell out for tax loss.

I think there must be or there would have been wording about a near-term resubmission.

You are actually spot on this one as there is technically risk due to the NJEDA bonds, but generics have that covered. Bankruptcy is out of the question.

I don't think we'll get any news anytime soon. CEO won't even allow Q&A after the NDA debacle. If we were to get bad news I am certain it would be this Friday or next week as most will be on vacation and mgmt will try to spread and minimize damage.