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Another massive 6% spike?
This is the biggest freaking joke I have ever heard. Please share what the total revenues are for this drug. Hint: it is in the worthless category unless you can self-deal.
Um no they can't. Generic business is around for a reason - because it is cheaper than the brand name. Even if they could charge higher than the brand name, the revenues are so paltry, the only person smiling is Nasrat.
Hammerlock on generic Trimipramine is nothing to brag about. Will profits reach into the dollars or tens of dollars. Complete joke.
Biggest fake news of the day! Lol
Not when you insinuate approval is guaranteed.
I believe you often state green lighted to approval, which is 100% incorrect. The ability to progress in trials has been permitted, but nothing more. It all means nothing until we actually get an FDA approval on the technology. We may be getting close and think we are within months rather than weeks as some would like to believe.
Maz - Epic's update on Oxy IR -
Per the Feb 10-Q:
On page 4, but is really like around page 29 after the F pages (financial section). Last sentence is the real update.
"Oxycodone 5mg, Oxycodone 10mg, Oxycodone 15mg, Oxycodone 20mg and Oxycodone 30mg (“Oxy IR”)
We received notification from Epic in October 2015 of the approval by the FDA of Epic’s ANDA for Oxy IR. This product was an Identified IR Product in the Epic Strategic Alliance Agreement Dated March 18, 2009 (the “Epic Strategic Alliance”). Oxy IR was developed at the Northvale Facility pursuant to the Epic Strategic Alliance, in which we are entitled to a Product Fee of 15% of Profits as defined in the Epic Strategic Alliance.
Epic advised us that the first commercial sale of Oxy IR occurred in March 2016 and such sales are ongoing."
Hope that helps.
Great post, thanks Maz. Per the Epic launch of Oxy I will quote the sentence & page from the Q. It was literally only a one liner that it had launched last year.
Except half your comment is BS. We know the Opana part is true though.
Perhaps naivety lured them into the extremely optimist scenario that no one would actually inject Opana. I was less worried about the 8 than I was in the FDA actually approving it.
Overreaction. Market always overreacts one way or the other and will correct itself. Endo is what a $3 billion dollar organization. Opana sales have been decreasing and I believe were recently less than 150M annualized.
Happy to see the FDA act in the best interest of society for a change in lieu of BP.
400K on the ask. Another dumping day.
Why do you not think it was LPC selling? That is what S-3 doc was for.
I believe this was answered a while back that the primary focus is US and getting to see if the tech can get through the FDA. For the most part other countries are more lax once FDA has approved. But if not, I can see them making this attempt to both Canada, Europe & China.
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.