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No, the issue is the CRL and the route the company has taken to keep pushing forward despite a faulty product - only now divulging it. Labeling complexity adds challenges to sell. Getting the product approved is one thing. Selling it to doctors with the labeling complexities is a whole new challenge.
Lol. I asked for a link to provide where Tmax was disclosed and it can't be done - because it never was. Data was hidden to public and, in fact, still is. How else are we being mislead?
Yes, it confirms everything that was hidden from investors that SequestOx is not 100% bioequivalent as the company previously announced. The company also disclosed that it knew of Tmax issues for 2 years and just disclosed them now. This shows no one knows what else they are hiding that the FDA can see in the data.
I know who has backstage passes
I think it's a good thought, but SequestOx is now a mediocre product at best with the added complexity of sprinkling & timing. It greatly shrinks the potential revenue. Perhaps this is why CEO stated this is only a 400M product at peak. He knew the Tmax issues all along.
I think we have had enough of these ignorant empty promises on behalf of the company. It has only been a few days since the last round were proved dead wrong.
The FDA already has issues with IR Oxy in market now. They don't want another IR with the same safety issues. They want something better. That is what SequestOx was portrayed to be these past few years, but we realized on Monday much was hidden to the public to our dismay.
Facts aren't BS. They just got hammered with a CRL on their lead product. That is reality. In case it was missed. the stock tanked this week.
Thanks for your thoughts. I think you meant one submission per quarter.
Nothing will stop Elite. Nothing! NOT EVEN THE FDA!! Thanks for the laughs.
How do you know whether or not SequestOx's Tmax falls within a clinically irrelevant range. If it did, the FDA would act as they have in the past for others.
Unless I am mistaken we do not have anywhere near the amount of data the FDA has on Tmax of SequestOx. We know The delay was significant for the FDA to go CRL route. Nasrat was aware of this issue. We are only guessing as to how significant the delay is until we get an adcom. It could be six hours for all that me know.
Easier said than done. These are patients with acute pain & need immediate relief. This isn't an extended release. They don't plan on when their pain kicks in and a pill is needed. It would be equivalent to torture to have them wait for SequestOx to take effect after a fatty meal.
One thing I just picked up is that the comparison with a light meal in the BE studies SequestOx was sprinkled. Fatty meal would be no different, but what this means to me is that it always has to be sprinkled any food regardless.
Purely from a business standpoint, I would prefer adjusted labeling now to start getting products out, real revenue being generated, off OTC & getting company recognition than adjusting bead. It adds more complexities & unknowns. I think we continue to invest & better the bead tech, but doesn't have to be in 1st version. It is a way to rollout a potential good, better, best strategy with different pricing tiers as well as better tech rolls in & old tech rolls out.
It would have to be sprinkled on a food that isn't chewed (e.g. yogurt, applesauce). In all reality, it becomes a labeling issue about the delayed onset.
Naltrexone beads are the deterrant to abuse. Plastic outer shell doesn't deter anything - just holds it all together.
I mentioned the same a while back and got my head bit off at such a suggestion. Funny how the scenario has changed.
Yes, actually. It is what creates the red tape in a bureacracy.
Please post anything from the FDA that says they meet for CRL reviews under 30 days. I will believe it then. I have seen several companies receive CRLs and all have had to wait 30 days to discuss the discrepancies.
Great question. Here is a couple links I have used in the past to distinguish NDA vs ANDA requirements. Lots of similarities. ANDA's on avg take much longer to approve - around 3 years I believe, but we have ADT at play so this will be interesting to see.
http://www.fda.gov/downloads/Drugs/NewsEvents/UCM167310.http://www.lachmanconsultants.com/2013/08/june-approval-times-for-andas-a-snapshot-in-time/
I think he had to show a few of his cards and be aggressive after the FDA mishap. Had he not this would have lost 80%. That call saved the PPS.
You need to check out more financials. Almost all companies stress & reference non-GAAP metrics to highlight parts of the business.
Based on Nasrat's comments this morning we will be seeing 2 ANDA's filed this year. Is that 201 & 216? I expect both to be filed prior to SequestOx resubmission.
It was very positive call. I think you meant ANDA's vs NDA's per Nasrat in last cc.
Nice try as you are obviously short or trying to get in at a lower point. It ahould dip below 0.20 today.
I think the meeting with the FDA will take place after the next quarterly cc, so there will be nothing new to divulge.
Very good point.
Perhaps issues with NDA itself prevented it even going to an adcom. Once addressed I could see it going to that step for labeling & safety review & discussion.
I am curious if an adcom is still forthcoming with the next submission.
But the directors couldn't get this right the first time. Doesn't that show what that talent can really execute?
It is frustrating. We all hope it is a quick turn. Could take much longer than few months. Interesting thought on pediatric study. Do you know if other ADFs submitted such? I didn't think so prior to NDA.
I think will stay in low teens. We have more cash flow than ever to support any additional trial needs. We had some big names join us and now have bigger payroll potentially for naught.
Will take 30 days to even meet with the FDA. Could be few month turnaround could be months or even years to resolve. It is only a guess at this point on the timeline until we hear more.
Wouldn't they just continue to negotiate. Why the CRL if it was just labeling? Pfizer is still negotiating labeling, but they haven't received CRL (unless I am forgetting). I think it is something more. I wonder if they think data was too good and want larger study to be done.
They will do about 20M+ with 15% profit split from Epic's drug.
I think Elite will continue to dilute & go it alone, but only they know the FDA's real concerns with the NDA. Except dilution will take place at much lower share price. Going to hurt.
Any thoughts on your end of the cause? If it was minor, I think the FDA would just work & negotiate through it with Elite. Very interesting as data & results looked strong. We aren't seeing all the data the FDA can see.
I don't even read the PMs. I delete them right away.
I think there is way more too it. It will just be conjecture for next month until we hear more. CC will be in month, but doubt that will reveal much about CRL.