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This is a different Elite as well. We don’t play in that space.
Different Elite, not ELTP.
Relisten to the last call and understand the timing of when most filings will be submitted - Q4 and Q1 of last year. We won’t hear anything on these until mid-late next year is my guess since they are no longer seem to be providing updates on bioequivalency studies.
Next news to break will be FDA approval hopefully, new CFO and year end results in June w/ 10K. Perhaps new distributor partner for Doxy soon. Will be interesting to see what insights are divulged from geography standpoint for Adderall in Israel - US vs OUS/global.
More often than not, people leave bosses, not jobs or companies. 2 CFOs departing in about a year is a red flag. If they change auditors as well…
Took about 3 weeks to announce hired replacement for Carter. Let’s see how long this one takes.
Scripts are a best practice for the structured part of the call. This holds for any publicly held company. When they go off script is where risks begin.
Just 2 in recent past
Lol If Carter is the high bar to set for comparison, we have issues.
Could bring in consultant as temp CFO, but may lead to delay in 10K.
That’s not good. 3 CFOs within a year.
All depends on how big approval is they are anticipating first half of this year. 4 ANDA goal has been delayed and those that will be filed are primary going to be crammed in late this year or early next + layer on 10 months review time + any delays for FDA. Not sure there will be much impact this year or next, which is why Nasrat said 4 ANDAs this year and 4 next IF financial (ie self funding) works out. He’s also really worried about Lannett and their recent Adderall approval. I’m sure they are getting Adderall IR ANDA as well, which leaves Elite with the proverbial bag when that day comes, which is why Nasrat is looking for a new distributor. Hopefully he finds one and doesn’t build out their own sales staff. That would be an absolute nightmare at this point.
Considering all other opioid products didn’t pan out or were sold off…
We haven’t had to refile yet. How many times did we have to refile with the SEC due to Carter?
Fascinating. Let me know how your trading goes today.
Opioid crisis occurred
All relative, perhaps he was referencing Zimbabwe dollar. He’s rocking that one.
The largest shareholder may say otherwise, but only he knows.
That conversation won’t be had with Lannett, but rather a replacement for Lannett. Lanett has Elite scrambling.
I’ve been on doxy for respiratory infections in past and have a kid on it now. No allergic reactions from either of us.
An interesting surprise, but will have minimal impact. This is another tiny drug with several players already in the mix. With Nasrat not counting on an approval, next steps towards launch may be delayed if ducks weren’t in a row.
That’s all great news. This should be an interesting year from a clinical trial and FDA submission standpoint. Let’s get that R&D moving. Now that Covid is slowing down significantly there is a major backlog in many industries in trying to catch up, pharma included.
Last day of the fiscal year…
Place of manufacturing is critical, but so is the API/raw materials. I think about 70% API is sourced from outside the US.
This almost isn’t worth responding to due ignorance of millions spent in R&D over the years under this CEO that amounted to nothing other than a few fire sales for a few approved ANDAs that never got pushed to sales. Millions and in R&D (excluding time & delays) that got flushed.
Because there is no news to release…same old same old until these ANDAs start getting filed later this year. We should hear about FDA submission mid-year as was communicated in last cc.
As the company can execute R&D and get ANDAs approved and launched the bid will rise. Lots of R&D spent over the years on products that didn’t make it to finish line or that were sold off. Next launch will determine how big of a next step company can take towards stabilization (profits and share price).
…Mikah has share in profits and is owner of the ANDAs
Would be nice for shareholders if that were the case. Hoping we see some movement on Dexcel as well.
I expect we’ll hear more over next few months, probably near time of next call. If it’s a small drug, we’ll probably hear about it after the call.
Well, he did say “this year”. Last time I checked it was still 2022 for 9 more months.
Primary source of revenues and CFP is at risk. Lots of uncertainty as to next steps and Adderall distributor. If they go solo, well, investors will have to simply embrace the suck.
The 10K in June - long way away.
The US is a nation of laws. This is the typical safe harbor protection. If they didn’t have this, they wouldn’t say anything forward looking, but report actual results only and wouldn’t answer questions.
Nothing was stated in subsequent events so it would be an unknown. Doubtful to tap into LPC with current cash on hand.
Or from embarrassment that it’s another small drug that will potentially be launched. Nothing has been divulged.
That is the hope, but an unknown. Zero insight has been divulged on market size.
Interest and ability execute are two very different things.
It’s also why the CEO stated there may be delay in funding R&D. Risk communicated appropriately. Don’t be surprised when it does happen.
2013 valuation was based on opioid potential. Company had to completely re-engineer itself. Not apples to apples comparison. Elite sold off their opioid like that would have brought in stable and growing revenue over the years.