It's a way FDA can delay making a full decision. Sequest could be approved by July 14th, but FDA may postpone labeling decision until a later date. Need approval + ADT labeling to move forward.

Like I said, they are living in the past and can't conform to today's playing field. It will be to Europe's detriment. You will see.

No borders are 100% closed. This is today's reality. Glory days of decades ago is long gone and they can't adapt to the new norm.

Cash is received immediately. Revenue is recognized over life of agreement. Cash doesn't equal revenues. That help?

This is basic economics of economies of scale.

Sad day economically. EU countries could compete with China and the US, but they can't individually. They forgot that they learned that 20 years ago. History has been forgotten and thus will repeat itself.

Unbelievable. Never thought Britain would exit. Scotland stays. What a sad mess. Britain is paving way for others to follow suite.Will be too much for Germany to handle. Sad day for Europe's future.

Article was posted here previously and was released prior to horrible conference call or it would have had a much different tone.

Couch - but isn't this a multi-billion product? Nasrat says otherwise.

FDA pre-approved their trials & said they need to do another trial. Set them back another 2 years.

Don't you think if there was no competition that Nasrat would have stated that SequestOx potential of the 400M market would be 100% instead of as low as 1%?

Very well said & completely agree.

And for the hundreds of other companies that have done the same.

Everything is rainbows and puppy dogs here. Completely ignoring the recent conference call. Picking & choosing what they want to hear & ignoring what was said. Unbelievable!!

Never know what the FDA will approve. Why would a company spend millions and millions for drugs that never get approved. Doesn't add up.

Are you saying you are more aware of SequestOx market penetration than the CEO? Wow!!

Throwing dice doesn't have same connotation as "slam dunk" or "the FDA can't stop us" as some here claim.

Same reasoning could be applied to any NDA that takes years. Many obtain approval, many fail as well.

If there were no competitors we would reach Nasdaq faster than 2-3 years, but many here ignore reality.

CEO stated a market of 400M. Nothing more.

Nasrat has stated in the past that SequestOx market is 400M, not multi-billion.

Again, only vowed to remove non-ADF generics.

Except for the FDA, that is. Lol You keep forgetting that little piece called the FDA. They can keep delaying and delaying SequestOx, which would lead to more and more dilution. Nasrat mentioned just yesterday that there would be further dilution.

The FDA has already disregarded this new change earlier this year. What makes you think that they won't do it for e
Elite?

You somehow skipped the part that Pura doesn't have any focus on pain management in the US. That is critical.

His reasoning as he has stated in the past hasn't changed, just the timeline.

He did also state previously that he would be working on launch batches displaying further confidence. It is being interpreted that his confidence is waning due to not creating launch batches.

I do agree with your comments, but it is a stark contrast to his past tone. Some timelines have been reestablished (e.g., Nasdaq), confusion on Eli-202's value add & complete contrast to what many posters claim here that are far from reality.

CEO sounded like a politician looking for excuses trying to blame his comments of potential further dilution & delaying FDA approval & labeling & Nasdaq to prior leaders of the company. That is a poor excuse. He knew very well what he was getting into. Plus, he has been in his role for a while. Very lame excuses.

Just because you don't spend the time to look for it doesn't mean it doesn't exist. It absolutely exists. Why do you think there was some heat during the call? It was due to trying to hold the CEO accountable for prior timing & expectations he set.

Do some dd. Been more than once.

Ummm yes he did

Not doubting, but just a realist. Nasrat backtracked on Nasdaq timing as well. He is resetting expectations to reality, not to the picture many posters here have created.

No SequestOx approval on FDA website this morning despite what some here wanted you to believe. As I mentioned last week, this should be a regular conference call.

That is a forward-looking statement so even if it doesn't happen the CEO is protected under Safe Harbor language.

So far FDA has stated they will only remove generics, not branded opiates that aren't ADF.

Not a reputable source...yet.

Progression is stopped.

I think ELi-200 has a solid chance of approval. We only know what we've been told, which is filtered. Data & studies really look fantastic. We are blind to behind the scenes conversations, concerns, etc. We will find out soon enough.

From a pricing standpoint, Elite has tech to demand a significant premium, but not sure that is wise on their first product. I think the CEO is wise enough to avoid price gouging accusations in a very sensitive space regarding both pharma & opiates. In addition, I think some insurance carriers and states are migrating to paying for premium w/ ADT labeling, but legislation always lags reality.

Next couple of months are going to be a joy to watch. I think Monday's cc will be normal financial review. I don't think anything new will be released. I will be pleased to be proven wrong on this one. I think CEO is a class act & brilliant mind. CFO on other hand - not impressed at all.

10-20% of 400 million market is about 20-40M in ELTP pocket after 50% split. PPS with 30x multiple brings PPS to about $1.50 on this product alone.