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I agree with your thoughts. Omission does not equal approval. I tend to limit my responses to a few sentences. Glad to see your expounded response on same wave length.
Suitability, not stability as you misread.
You are completely missing the point. Until an ER or IR (which isn't going to happen) actually is approved by the FDA the tech is not validated for commercial suitability. FDA can keep adding trials and drag this out for many more years. Only the FDA will have access to the nitty gritty details. Tmax for IR threw everyone for a loop since it was kept from investors. We don't know what concerns the FDA may have until an approval is given or at least an Adcom to discuss.
That is the issue. We don't have the granular data. We weren't aware of the Tmax issue until FDA rejection.
Good results for sure, but this is no slam dunk, especially with how quickly the FDA can add additional requirements. This will continue to drag on.
Let's not pretend the Tmax workaround is the only issue at play. Remember how no one was going to stop Elite with SequestOx? We don't see all the data that Elite does. I am incredibly skeptical as we cannot analyze the real data to the degree that the FDA can.
The tech isn't proven. The CEO expects the FDA won't have any issues with with ER dual bead or hard shell tech. The company relies on share sales to buy puny drugs (e.h., Trimipramine) from the CEO's other company. SequestOx IR tech failed BE trials twice. Deadlines and major hurdles continually pushed out and missed altogether. Should I add a financial restatement since the CFO doesn't understand basic accounting.
Here are just a few reasons to be realistic about this company. There is no certainty whatsoever here. Don't be fooled.
They acknowledged that they did not hit top line results and were expecting better. Program has been halted. With the insights they have if they had faith in the tech for IR they would continue. Not happening.
He already is following that counsel. He gets paid in these crappy drug deals via Mikah sucking future cash flow. Yippee Trimipramine!!
He already did. Anything else related to the program being halted is a gross misinterpretation.
I am curious how many of these are IR's that are now scrapped along with SequestOx.
It takes 6 months to get a meeting with the FDA. It takes another 6 to review SequestOx. There is no time to fix what is broken & run new trials. Nasrat's comments on 6-12 months were excluding SequestOx. He was referring to having hopefully receiving an ER approval and commercializing it within a year's time. Only ANDA's are on the radar now.
This is pure and utter garbage. Zero truth to this. Zero.
Agreed. Will be interesting to see what becomes of SunGen as well since one of 3-prong strategies (NDA) is now defunct. Big bummer here is the dilution story will continue for at least another year. One question is whether we can see approvals fast enough to avoid LPC v4.0.
I agree in that Nasrat clearly needs to put up or shut up. IR has failed or at least halted for a couple years at best. I am not entirely sold that the ER line works. We know Tmax isn't going to be an issue, we know the products are BE, but it is the data of which we don't know that is not yet public that concerns me. TMax through us all for a loop and yet was known by the company.
I don't think we will get an ER response from the FDA for several months. ADT is not exactly your run of the mill ANDA. I would love to be wrong, but we'll see.
Completely disregard that SequestOx never made it to the finish line either, but here's to pure luck & hope!
I agree with your comments but it was the top line end points directed by the FDA that stopped SequestOx. I see it as Elite hitting the brakes from the bar set by FDA.
Significant amount of unknowns here.
The results did not meet top line goals. The SequestOx & all other IR products have been stopped after spending millions and millions. The FDA stopped them in their tracks.
Must be why the tape was painted. Lol
They also have hundreds of millions more in revenue coming in the door.
It is just as likely as SequestOx approval. Extremely slim chance of happening.
Elite's SequestOx....is dead. Let me interpret. It will not move forward.
More questions than answers, but I am just befuddled as to the halt altogether. I don't see any movement on this anywhere. We are only seeing a small piece of the picture and may not know the real results of it being shelved and no further updates for at least 8 months (6 month to get meeting + several weeks for official notes) at best. He may try to ride this one away quietly into the sunset...
Could they simply redo the study with a larger sample? There is the redundancy in cost, but I can't imagine this would be the solution. I think there is much more to this story that we are led to believe.
Per Nasrat, the partnership was awaiting SequestOx results. They came in like hot crap that no one wants to touch. Wonder why no announcement has been made here. Hmmmm...
Weird. I have no issues opening. I read one of the articles last night on Christie's committee missing their 2nd deadline in putting together plan for opiates.
That is my favorite gauge. Lol
That I agree. The breakdown of ELTP is not from shorting, but rather lack of fundamentals & increased uncertainty. Investors hate crappy results, but they hate uncertainty even more. Much tougher to model out.
You can short penny stocks through Interactive Brokers and any other broker not based in US. In addition, you just need to understand the legal & tax implications for doing so as a US citizen.
10% is much more valuable, but it is just relative. He is leading all down a path of "hope".
Let me ask you this. Why do you think an Adcom was passed up to discuss labeling? SequestOx issues go well beyond the labeling.
Except for the fact that the CEO stated "we were hoping for better results" and stopped all studies and further pursuit of the program. Flopping like a dead fish out of water.
Significant upside in company does not exist on generics alone. IR was needed.
Going back to Carter's baseball analogy - the company will only have ability for a base hit every now and then. No doubles, triples, home runs or grand slams. There has been more fouling out and screaming touchdown as Elite aims to have any of their tech approved.
Remember how confident Nasrat was about SequestOx with all the studies proving the tech? Well, reality bites. Platform means squat without FDA's approval on at least an ER ADT.
That was a dead cat bounce.
But wait!! Revenues are "rising"! LOL
All prior CT's that have expired have been worthless info.
The real reason for the CT is to hide the number of jelly beans in the jar on Carter's desk. He counts them every morning since there are no revenue dollars to count.
And how long does it normally take for the ER ADT's to be approved? How about the most recent? It is well beyond 10-12 months.
Or rather this is what happens when he sells his shares, he hides for a bit.
No, nothing to do with Dr Reddy
Not fraud. Just continuation of a lack of attention to small details...like the minor Tmax issue. No worries though. Nothing will stop SequestOx. Not even poor results or the FDA. Santa Hakim is here to make things all better and leave a big turd in your stocking.