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Good insight. Can you fix the dates? Can't tell time periods.
Amen! Great post. Hopefully game of charades is behind us and we can really get this pipeline accelerated.
He is bringing some levity to the board.
It is pending FDA approval. Look at Elite's generic page.
He has admitted to screwing up. Funny how that is ignored. He is hiding behind no live Q&A similar to how you hid for a couple weeks after the CRL. LOL
Quote from that article:
"It should be noted that these technologies have not yet proven successful at deterring the most common form of abuse — swallowing a number of intact capsules or tablets to achieve a feeling of euphoria.”
Want to describe how Elite is different here? They aren't.
How do you know they were filled? Could have been pulled due to budget restraints or consolidation of roles.
You are correct on that, but CEO's cocky attitude on SequestOx only made things worse. He dug his own grave. Now he is tucking his tail preventing Q&A dialogue during 2 most recent calls. May change for Q3 call, but doubt it.
Not sure about your top line comment. Sequentially, revenue tumbled close to 20% and margin took a hit. Year over year will be good, but sequential growth shows momentum. From a fiscal perspective, last quarter was underwhelming at very best. Probably no Q&A again.
I'm sorry to hear that. This opiate crises affects so many. Sadly, Elite's tech doesn't work with fentanyl. Hopefully, some company can find a way to defeat it.
Pfizer isn't obligated to disclose anything about Troxyca or Embeda. I looked quickly through the last several transcripts of investor conferences through NASDAQ IR and they weren't mentioned there either.
Good for you. I was impatient and put a couple orders in earlier this morning close to yesterday's close. Will put in another tomorrow.
And that, my friend, is absolutely fantastic. Generics, like any other new product, don't go from 0 to 60 in a matter of days or weeks, but rather months and in some cases, years. Ramp up takes time, especially when crowded markets exist. We have a mixed bag here. One factor that too many board members are missing here. Generics should stop dilution & allow faster acceleration of R&D. 2017 is an alley oop for 2018. This & next year have the potential to be unbelievably positive for investors, regardless if you purchased at 0.04 or 0.80. Looking forward to seeing how the next chapter unfolds.
Until it is actually launched, there is zero benefit to Elite since there can be no comparison study, per Nasrat's plan. Looking forward to the next update.
I don't disagree, but much of politics takes place behind the scenes. I think there is more to the SequestOx situation than investors have been led to believe. For example, we weren't aware of the Tmax concerns until the CRL when this was well known by the company. Investors are neither privy to the data nor the closed door conversations with the FDA. If they don't receive approval this time around, Nasrat should be a VP, not a CEO. All fingers point at him and these flubs along the way.
Hopefully this is the last hoop me have to jump through. Been a long marathon.
Yes, I am aware, but the FDA is going well beyond approving drugs based on safety and effectiveness. That is the issue that compounded and morphed into the bureaucratic organization that exists today searching for a way forward in the dark.
Now let us remember we have already been set back 2 years to accommodate the FDA commissioner. There is unknown risk when Elite is on the agreed upon path...yet again. The FDA calls the shots and one thing is for certain - they are consistently inconsistent.
No law to change at all. This would be based on the actual and original purpose of the FDA as they were originally commissioned, which is to ensure safety, not everything else that has been added slowly over the years. This would create extreme efficiencies in time & cost compared to the current FDA model for both the organization & pharma companies.
Let's be honest. The financials still suck. The expectation that has been set is to be cash flow positive mid year which is great but the topline is a far from the billion-dollar company the CEO is set out to create. Will 2017 be the year that it all comes together? I firmly believe so, but time will tell.
If you can't beat the DOW or S&P you simply shouldn't be trading. That is the absolute bottom baseline return you should get. Yes, the market & especially individual stocks can be timed. Why do you think companies buy their own shares? They do so at a discount to where they know the stock is heading.
Is Elite allowed to argue facts?
Pfizer hasn't saved Elite anything yet. If Pfizer doesn't launch then on this assumption means Elite needs to spend $30-70 million more. Lovely.
When was Perc filed? Can't recall offhand. Was it Q3ish?
I believe it is expected for us to be cash flow positive midyear even when including R&D. There should soon be no more need for further dilution.
I think it is best to refer it as value potential. The FDA has yet to sign off on our technology. We are inching closer and closer to The day when that potential value becomes real. The question becomes will 2017 be the year for Elite or will be continue to get more setbacks?
Based on the time it took to get in and have and end of review meeting I believe it is clear that we have a class two. I think we will resubmit by the end of Q2.
I don't think we will be delayed that long. In vitro & vivo studies should be done by Q2 followed by a submission. The FDA has already reviewed & studied the tech & results. I think we'll get an expedited review and get a response during Q3/Q4.
I agree with you. This is not due to FDA chief change. Polymer issues should have been fixed prior to original submission. This comes down to sloppy work and poor execution trying to ram this one through.
No such thing is ever a guarantee with the FDA, but we will have knowledge of all the requirements, processes, procedures & where to drive further efficiencies. This will be a huge win to have this done and behind us.
With the looming earnings release in the next few weeks I highly doubt there will be open Q&A again.
I think he knew this back when he pushed out NASDAQ goals ~ 2 years. This was said early 2016, I think.
The formulation fix is by far the best long-term solution for our entire pipeline. Hands down. There is no argument here.
I think Nasrat has known for a long time that this was the right route all along. This will alleviate concerns and ensure we don't have a product DOA.
Very interesting that it is a formulation issue with SequestOx.
I think you should work for the FDA because they are missing the loopholes too. Pure garbage.
I agree with you here unless the plan that the FDA & Elite have agreed to is so simple & clear, we may see some solid movement before approval. SequestOx is just the beginning of a large, growing & beautiful pipeline. I am frankly tired of relying on breadcrumbs. This is the year breadcrumbs will be just that, breadcrumbs, instead of the primary revenue.
Lol There is no analysis.
I have many times and the company is addressing the issues presented. Please clarify, otherwise this claim has zero substance.
I do recall that now as well. Hopefully better than a "hit by pitch".
My comment didn't pertain to just OxyContin. It was a concern about the entire backlog sitting in the FDA's lap.