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Couch's comment was a mere 3 months ago. Just goes to show how quickly the tide changes.
But the FDA did stop ELI-202. Just another reminder that nothing is a sure thing with FDA, even when comes from mouth of a CEO.
Yes, you are correct. Has been approved for couple years now. Poor execution has led to its demise.
An absolute disaster that once had hope.
Many factors in play here. Fact is reg oxy is standard today. Elite has a potential disruptive technology and signs are looking good.
This is a cc to discuss financials and what can be shared. When we hear from FDA another cc will be held. This is standard practice.
Of course there is competition. It is regular IR oxy. Anyone who says otherwise is being dishonest or ignorant. The non ADT version does not disappear overnight & will continue to be prescribed until approval, marketing & education take place. Depends on pricing as well. Not a done deal at all.
Good thoughts, thanks. I think there is nothing special about cc being pushed to Monday. Could easily be coordinating travel schedules. Would love to be wrong here.
I find that annoying similar to yesterday's IPCI pumper.
It is really unbelievable as many other big dogs have failed. In a month's time we'll know how bright the future really is.
I agree. First will be hardest to get & I hope we have accomplished & provided all that FDA needs. I like Nasrat's vision of a conveyor belt. Couple more NDA's this year and probably same the next. These are very nerve wracking & exciting times. Biggest hurdle that ELTP has been waiting for years is coming up in less than a month.
Don't put words in my mouth. It will happen, but I don't think immediately upon approval.
Funny how you miss CEO's hesitation when about stock reaching $2 on its own. CEO has stated that a reverse split may happen to help get us to Nasdaq, which means there is risk that approval alone won't get us there. We can't pick & choose what we want to hear.
Was also before significant dilution to fund trials and overhead. That is a good valuation back then, but is old. Upon launch forward multiples will be based on penetration of SequestOx. Will not be overnight flip of switch.
In 6 months time we should see some good traction with SequestOx & bring in solid revs to support other trials. In addition, we file 2 more NDA's by year end + time for FDA to accept brings us out about 8 months + a little flexibility - around March. Just my estimate, but all based on approval in March.
Assuming SequestOx approval, I think an uplisting will take place within the next 8 months.
Please share with the board how much the restatements affected EPS?
In my opinion this is significantly raising the bar for when we partner with a bigger pharma. We now have some leverage & are setting expectations.
10k provides insight to share count at quarter end & also look under subsequent events that occurred between quarter end & reporting date.
Agreed. Very nice report. I was a little surprised at the additional dilution with the amount of cash flow being generated now from Epic's oxy deal. Hopefully, that is primarily behind us.
Some dividend stocks are as close to a guarantee that you can get. An AAA rating still exists and utility Industry is fantastic for dividends. Depends on how risk adverse you are in addition to how much of the portfolio you are trying to protect.
By the way, the AAA rating has a higher rating and that of the United States (e.g, treasury bills)
You are absolutely correct there is some risk as there is with all companies, but the risk pointed out from the 10K is typical wording. The risks that companies call out is laughable sometimes.
Very nice. Will go check out release.
I expect it to be filed after market close.
I don't disagree at all. I'd like to see SequestOx approved & distribution started before move to Nasdaq.
FDA does what they want. Haven't you ever seen the FDA have issues with trial design after NDA submission. I have seen companies work closely with the FDA & have trial designs approved only to be rejected by the FDA as it was another FDA dept that reviewed the NDA submission. Nothing is ever certain with them.
The more that we can accomplish while on the OTC, the better. As the fundamentals are strengthened and continue to build upon themselves, the more underrealized and larger potential the stock price has to run when it joins Nasdaq. The timetable will be clarified over the next several weeks.
It was a response as Soul claimed a rejection needs to have an adcom first. Data looks fantastic - I will not argue that. We'll hear more from FDA soon enough.
I should add either as cash received (hopefully) or a liability still on the books. We can't forget payment terms tacked on to when it was earned. Perhaps 30 days, but maybe longer with Pura now in the mix.
FDA doesn't need an adcom to reject any NDA.
I think she was referring to the fact that it is in the financials that are yet to be released.
Wouldn't see extension until after due date passes. We should assume everything will be submitted per SEC guidelines until there is reason to worry about it.
I was offered a job at their corporate office a few months ago. Would have been a worthwile discount...
The board is getting a little uptight. Let's not get panties in a bunch.
Lol. Yes, this is precisely it. Have till tomorrow to file, but still weird no cc announcement.
I'll speculate Carter screwed up financials again.
Revenue growth over prior quarter, but finances are secondary to SequestOx approval. We'll also soon get milestone & 15% profit share w/ Epic.
I have seen other companies in similar timing dilemmas. The cc is still held as usual and another cc would be held to discuss any product approval & an update to strategic direction.
How many here will blame MM manipulation?
I am actually dumbfounded as to why it hasn't yet been PR'd. Nothing relating to conf call either. In my opinion they are either waiting for some news or are having challenges with their accounting firm wrapping up the year that may lead to a delay in filing. I have seen the latter happen with smaller companies that get deprioritized. We'll know more next couple of days.