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No SequestOx approval on FDA website this morning despite what some here wanted you to believe. As I mentioned last week, this should be a regular conference call.
That is a forward-looking statement so even if it doesn't happen the CEO is protected under Safe Harbor language.
So far FDA has stated they will only remove generics, not branded opiates that aren't ADF.
Not a reputable source...yet.
Progression is stopped.
I think ELi-200 has a solid chance of approval. We only know what we've been told, which is filtered. Data & studies really look fantastic. We are blind to behind the scenes conversations, concerns, etc. We will find out soon enough.
From a pricing standpoint, Elite has tech to demand a significant premium, but not sure that is wise on their first product. I think the CEO is wise enough to avoid price gouging accusations in a very sensitive space regarding both pharma & opiates. In addition, I think some insurance carriers and states are migrating to paying for premium w/ ADT labeling, but legislation always lags reality.
Next couple of months are going to be a joy to watch. I think Monday's cc will be normal financial review. I don't think anything new will be released. I will be pleased to be proven wrong on this one. I think CEO is a class act & brilliant mind. CFO on other hand - not impressed at all.
10-20% of 400 million market is about 20-40M in ELTP pocket after 50% split. PPS with 30x multiple brings PPS to about $1.50 on this product alone.
Yep, sure
The post was on Eli-202, not 200. My aim is to provide balance and realism to offset the ignorant baseless pumping.
Love how you twist words and pump this stock incessantly. FDA stopped ELI-202 in its tracks.
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.