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I was thinking more along the lines of:
How many more drugs does Mikah plan to sell to Elite? As a quick follow-up, will any actually earn an ROI?
You are correct. Accounting for milestone is spreading revenue over course of multi-year agreement. Associated expenses for the agreement (e.g. Legal) would be amortized over the same period.
Yes & no. Elite's primary tech will not work with fentanyl; however, no one starts out on fentanyl. Abusers add it to other drugs to get a better high. Elite's tech is designed to prevent abuse at the onset and thereby will indirectly drive fentanyl usage down. All theoretically until FDA says yay/nay on any of their ADT line.
Sounds like Elite isn't going to get a response on ADT generic Perc or Norco this year. Hmmmm.... now the 160M shelf offering makes sense. Keep spending millions loading the pipeline without any FDA approval so we spend millions more doing additional studies. Great idea. I do like these side deals. Trimipramine was a sweetheart of a deal. Couple more years of deals like that and we'll be set.
This is one of our current tiny generics. Shouldn't expect any bigger revenues from it.
You are right. It was just labeling. :)
Potential new MIKAH/ELTP deal in the works?
On May 31st FDA approved Phentermine Hydrochloride for MIKAH. Looks like 5 different oral tablet strengths:
ANDA #040448
ANDA #040460
ANDA #040190
ANDA #040227
ANDA #040228
We all know how these deals are such a huge benefit to Elite. Lol
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=report.page
Nothing that is going to move the stock. May be even negative comp as current generics are not growing, but help offset R&D. Future news will be what moves it - BE SequestOx, partnership, FDA approval on generic Perc or Norco.
CC & 10-K are next expected news/updates followed by BE update for SequestOx in July. There may be another ANDA submission near term as well. For the last few years CC's have consistently dragged the price down. There is always "hope" that some big news or agreement will be reached announced during a CC. Never happens and stock craters.
Also, Epic/Puracap partnership update is expected for SequestOx after BE results, but not before then.
Management doesn't have to provide this visibility. It is completely up to Elite as to how transparent they want to be. If Merck took on a new drug & it doesn't sell well there will be no line-item breakout. There may be some discussion during Q&A around the ramp up expectations (forward looking), but probably not the actual results themselves.
Or the posters that claim it's real. lol
Where are the FDA notes to prove it? I'll wait (as is so often rudely quoted).
Management screwed up. There must be agreed upon documentation of action items, don't you think? There would be legal liability based on this agreement, no? Hmmm...
I'll put my money on the reality of the situation. When was Eugene brought on? Oh yeah, prior to the SequestOx CRL.
Was that labeling issue in the notes of meeting with the FDA or a misunderstanding by management?
Many factors at play here. We are now on our 3rd FDA Director dealing with SequestOx. Each has a different view of the science, data & risks. Science is sometimes more gray than black & white and this is no different. I am sure Gottlieb will want to make his mark on this one too, protecting BP, of course.
That is impossible to say. BP is always getting sued. This is typical corp America, but Pharma being more prone. Often settle to go away. For little Elite, one lawsuit could wipe it off the map.
Oh that's right, our knowledge of opiates & science is ever changing, just like all other areas. I am disappointed it was delayed, but will hopefully have a win in the end. Earlier approval would have killed the entire pipeline with a crappy Tmax like that & set up company for major major lawsuits.
How many branded & generic competitors are in this space? Funny how topline is mentioned being all inclusive, but reality is ignored.
This explains the exact same Tmax issue SequestOx ran into while also highlighting the risk to the brand that I have mentioned before:
"He agreed, however, that most patients wouldn't want the new product because it would cost more."
Cockiness leads to ignoring vital truths. One thing that we have clearly seen is that attribute here mixed with shenanigans.
I was referring to a private post. Oh and don't forget how the stock always rises fictitiously before dumping takes place. MM's have LPCs back.
Nas - I assume you already saw the 8K from this afternoon. I was referencing the $160M shelf offering.
This has zero to do with Elite.
It will make Elite great again! Oh wait, we're still dreaming of the first round of greatness.
Love how Tripramine isn't even in the 8-K today. But but but I thought it was already bringing in profit? It is, for the CEO. Lol
Feel free to tell me the value of the deal after CEO lined is pockets. I'll wait, but won't need to. Pure filth.
A penny for your thoughts, which is equivalent to Trimipramine profits.
Was it replaced by positive BE data? Nope! Just another delay...
I can assure you it won't be coming from a hat...
Oh, of course, while filling his pockets merrily along the way. Can't be denied with these non-arms length transactions. Board is delusional, which is usually the case with OTC companies. Heck, that is almost true with all boards, regardless of size.
Did he also cry out for someone to please manufacture Trimipramine cuz the world is in more dire need than Nasrat's pockets?
Maybe cuz no one needs or wants it.
Teva had to give it up to pursue their acquisition. Tech had zero say.
You didn't stutter on this yet, but you will as the dates pass by.
Always fun to read your posts. Regardless, of how the stock is doing, the posts consistently bring on some good laughter.
We just bought Trimipramine. That won't do it? Lol
This is potential over a series of years.
Trimipramine!! Hahahaha! Rofl
You do realize the nation is on vacation on Monday? :)
I am talking sequential, not y/y. As you say, facts are facts and not malleable.
Dec 16: $2.3M
Sep '16: $2.7M
Jun '16: $3.3M
Mar '16: $5.2N
Dang those stubborn facts! A whole year of sliding revenue. When new sales products are added sequential quarters are more important than prior year to show momentum. For the last 2 quarters, "delayed shipments and quotas have been the scape goats. This is a piss poor excuse, plain and simple.
Lots of talk, no action. Trimipramine might cause a rounding adjustment each quarter if we go to the next decimal. Woohoo!
It has dropped during, but drops more consistently after. With no pending SequestOx news until well after the conference and falling generic sales quarter after quarter this may very well be a challenging call. Knowing Nasrat's history of opening his mouth and the stock dropping, history can be a very good guide here.
Nothing he can do on Percocet filing. Crappy Trimipramine probably counts as ANDA for the quarter. LOL
Next step will be selling generic Flintstone vitamins. Wait. That would actually have a much higher revenue stream than Trimipramine.
I understand your frustration. I really do. I think you are looking a little too deep here. The exclusions have nothing to do with bioequivalence. Simple criteria is simply not being met to have data included. This could easily be people people simply not taking the pills at the right time, eating when taking the pill, perhaps some tried to inject it, etc. With this small of study we want to ensure the criteria is met so we can analyze the data appropriately. If data collected is bogus, the analysis will follow suite. The only red flag for me is that we have another freaking delay. Camargo is ensuring exact execution of the subjects inclusion/exclusion criteria that is holding up the process.
Now I personally think that this will also delay the SequestOx submission later this year to move to Q1 2018 assuming all goes well with BE & dosing studies.
Not at all. If you can't get all of your subjects to fit the criteria then you simply wait until then. That is all there is to it. This has zero to do with the results.