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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.
He is the largest shareholder. Please provide a logical reason as to why he would do that?
Per the FDA website, they actually approved 90 in '15.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/ANDAGenericDrugApprovals/ucm482213.htm
I may need new glasses, but at first glance it appears no ANDA has been approved since 2012. They are all sitting as "pending". I know much has been done over the past year or so to clean up the backlog, but this just goes to show the bureaucracy of the FDA. Can't keep their head above water.
That is a rarity and don't think it is a realistic option.
The float from ongoing dilution is a noose around their neck. This will permanently go away after the tech is approved and unexpectedly large sales are rolling in or after a reverse split to get us to NASDAQ - assuming the company doesn't get acquired. Company still has an uphill battle. FDA needs to green light with an ER or IR approval.
By the time Elite submits the ANDA, the timing for an expected response from the FDA would be around the Aug '18 timeframe.
Not one substantive comment was made about these "loopholes". I am eager to hear all about it. Please enlighten me.
Thanks for insight on Teva.
Goofy b/a this morning on Scottrade:
bid: 0.175
ask: 0.1725
really?!
Wow! Let's hope FDA applies a consistent framework to all.
Very interesting. Great to see they received labeling for all 3 routes. Very promising. I do not know much about Vantrela. What is the mechanism of deterrence?
Lasers, these tiny generics aren't even close to being in the same ballpark.
Could all come down to a pricing game. Hoping Nasrat plays this card right. The first ADT price will set tone for entire pipeline. Set too high & get lower sales result. This is a game of strategic finesse. Pricing too high has slaughtered companies that thought their tech deserved it.
That would make perfect sense. Very interesting.
Purdue has ADT for injection & snorting. ELITE would have to beat on price and/or receive oral ADT labeling to be prescribed.
They stated bioequivalency. What else do you need to hear? This is similar to all other PR's announcing BE, so nothing new here.
Read article few days ago that nothing has to be put on clinical trials.gov. It is up to the ethics and transparency policies of each pharma company. Study in article rated transparency of major pharmacy. Some did ok, some very poor regarding transparency to public. Mixed bag here. Very interesting.
Makes me wonder if this is good news released early to soften upcoming challenging news. Common IR strategy, but hopefully is just timing on still waiting to hear back from FDA.
Yes, very interesting on the physical deterrent properties. Do they have any patents here? I didn't think they did. Hmmm...
Well, are we going to repeat the cycle with a new FDA chief? We will know the accuracy of your statement in the next PR.
I don't disagree with you, but I don't think the FDA is having Elite jump through hoops for naught. I think Elite missed something along the way and is now paying the piper. We have no idea what the discussions behind closed doors entail, but we'll be able to put more pieces together soon enough.
We all need to be patient as we are all in the dark regarding next steps. We have no idea on requirements or expected timing.
This is conjecture just like most other comments here, however, the FDA has to act faster than one year after resubmission per their own guidelines. Now if you said 6 months then there would be some truth and reality. We'll know more in 2 weeks time. Could be good news, but probably not based on all the other setbacks that history shows.
I think it is well beyond just a paper shuffle. The FDA would not reject the NDA and wait 6 months to tell Elite about a simple paper shuffling issue. I think there is much more to the issue.
Perhaps I misinterpreted this PR back then, but I thought these were proposals for an additional much larger study or studies that the FDA would require ELTP to execute. That is the news I was waiting on in the next PR to find out both the fiscal and time setback estimates prior to resubmission.
Funny, but not applicable to Elite's outstanding share count.
Some dilution? Stock has been diluted to smithereens.