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But the most important factor is how many FDA approvals does the company have under Nasrat's leadership? Zero.
How about CRL's? 2
The current revenue is a joke as the doubling or tripling of nothing is still nothing. Meaningless and moot.
FDA approvals are the real deal and we'll see if the CEO can execute after these fumbles.
The only thing that is clear is that the company is batting 1,000%, 2 for 2 for CRL's. Batting average that makes Babe Ruth blush.
That is what I quickly read before validating on way to work. Extreme lack of detail orientation. I should have known better to confirm b4 responding.
Anyone can post that crap here. "No one will stop us." LOL We just need to figure out what to do, says the CEO.
Only shelf it is on is the one in the waste bin.
Haha! I stand corrected. Thanks.
Umm no it isn't. The ANDA was submitted in Nov 2016.
That is the worst justification of sub status quo I have ever heard. An increase on barely any revenue still leaves you with...barely any revenue.
So glad we did the Trimipramine deal.
Eugene & Nasrat can't fix each other's messes fast enough. Always after the fact.
Must have been planned for this week of the conference. Great news for any who may be remotely interested.
The revenue is worthless at this point. How many more approvals has Nasrat received under his leadership? Goose egg.
No joke
I wonder how long this will set Elite back? It will take some time to prepare and then for the FDA to review. Is this another 6-month wait?
I also assume other submissions need to be amended as well.
I didn't say he lied.
But it isn't theoretical. The BE results prove the Tmax issues with a fatty meal. If American's had more of a Mediterranean or Asian diet, this would be less of an issue. Not the case.
It is clearly implied in the Tmax commentary, which is why it was rejected and given a CRL. The drug acts closer to an ER than an IR. Those who don't get pain relief risk taking more pills to full the immediate pain needs. Plain as day.
Elite knew about the Tmax issues and chose to hide this. They failed to fix it with a 2nd BE trial.
Now the issue becomes whether they can fix it. History shows their inability to execute makes the odds against them on the IR side. ER is different, but mgmt went all in and didn't plan for a Plan B.
Exactly, I agree. It won't be reaching the pharmacy shelves.
Ha! Lovely auto correct. Glad to see Karate Kid is a go to.
The only shelf that counts is at the pharmacy. Nothing in the works to even envision that. The company only dreams of resolving the issues at hand.
Funny thing is that it was touted that Camacho was he best thing since sliced bread. Oh how things change with failure.
Nothing. Marketing old posters.
Perhaps looking to take Trimipramine overseas.
Sorry to hear about you have been impacted by the storm. Glad to hear you and your family are safe.
That is my favorite comment of the year.
Based on the last call they popped that bubble dream saying they are considering going alone. Most stupid choice ever. Never works for tiny pharma.
Bottom of the barrel has to be scraped by someone.
Funny thing is, CEO's prior strategy was to not market until we have an approval in hand. 2x failed BE & CRL is a success?! Little late to the game.
And when Elite tries selling on their own, nothing will sell. Same outcome.
Because that is what every investor wants is maxed out AS and reverse splits. Brilliant strategy.
The past is an excellent determinant for the future. Trends over time are also a great picture. Although not perfect, Elite has shot themselves in the foot time and time again.
"No one will stop us!" - Nasrat Hakim, CEO
Except for the fact that the only green shoot here is a side deal with the CEO for Trimipramine, shows what management is truly capable of in the future.
That is not a case in point. Beginning finance 101 teaches shares outstanding is a basic factor in stock price. 800M shares outstanding is a far cry from AVXL's 40M shares outstanding.
Please don't disregard the reality of Elite's situation.
Interesting point, thanks. It will be interesting to see what unfolds over the next few months.
I completely get your point. We didn't get specifics on when the last FDA visit was, but we know one did take place recently. I keep my eye on the warning letter schedule to see if there are any updates.
Are you absolutely certain submissions don't go in line for review and are just being held up until this gets resolved? I am not certain that is clear.
Patience is one thing this company doesn't have time for. Without being close to cash flow positive, the upcoming R&D needs to be funded through dilution. Dilution at these levels is a killer.
Approval is great, except for the fact the company is looking to go it alone from a sales force perspective. Just another stupid rookie move. That would be devastating and incredibly disappointing and yet it shouldn't be a surprise that Nasrat is strongly considering that route.
That can be debated. R&D may not be material and is up to the company to best determine that.
If a product through various stages of R&D has promise, then yes, potential future sales are realistic. If there are large potential sales, it is in the company's best interest to divulge this to increase shareholder interest.
I don't think there is a requirement to divulge the testing going on in R&D stages. It could be questioned during a quarterly cc, but could be deflected with a political response. Lack of clarity to investors would lead to more uncertainty and a lower stock price with more volatility. I believe what we see is the free market taking care of the situation without any legal requirement.
How much market share is the huge Epic Oxy getting? Shouldn't that be a good gauge of what Elite can accomplish?
Goodness only knows what they can accomplish if they run with their own sales force.
Haha! Nice.
The board has gone to pot over the past few years, which coincides directly with the success of the company, or lack thereof.