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Gee- that was nice of Nasrat to give us most of the day to buy more shares before the official announcement.
Titan-Just the MMs using naked shares to try to hold ELTP back. It is sad that it is so obvious that 80% of the authorized shares have technically on paper traded. Something kind of suspicious about that. We have not even started yet. ELTP is just warming up. Wait until the naked shares are 2 times the AS. Longs will be laughing all the way to the bank.
You can clearly see how the Chinese Sungen/Puracap are "courting" ELTP. The Chinese are getting in bed with ELTP. It makes it real hard for Pfizer so they really have to come up with a ball-busting offer now. The Chinese were able to take advantage of the miscalculating and mishandling of ELTP by the FDA. In this case, Big Pharma shot themselves in the foot with bribes to the FDA and trying to stall ELTP getting on the market. It will cost Pfizer a lot more now. The US will lose valuable patents to the Chinese. The Chinese will be selling better ADFs back to the US for higher prices in the end. The Chinese market can surely support ELTP until the FDA decides to pull its head out of its as_! The Chinese really saw the situation for what it was-ELTPs patents and ADFs were just fine. The Chinese FDA or what ever they call it will give ELTP an automatic pass. The FDA screws up again and will cost Americans jobs and the trade balance will tip further in favor of the Chinese. Good work FDA!!!!
I am glad to see Nas has widened ELTPs focus. No sense standing around while the FDA figures out what is going on. This puts indirectly more pressure on the FDA. The Chinese will raise the takeover/buyout price. Pfizer looking worse every day. Nas saving lots of money by letting Pfizer deal with the FDA in getting approval then Nas comes in right behind them with a less expensive and far higher quality generic. Nas is absolutely going to bury the shorts, the hedges, and the MMs. It won't be long and the hedges will have to reset their skimming formulas on their super fast computers. You know they are pissed off. Thats why they like the SP to stay stable everyday and not go anywhere month after month and why we end up with such a strange SP at the end of the day like 19.000756489.
Hopefully he never has too! If the director goes he will take a lot of others with him. He will say - Why was I not informed? What kind of BS has been going on here? If he was sent to clean up the FDA, he failed. Next Director Please.
It does not matter. The FDA will approve Sequestox one way or another sooner than later. They must!!!!if the current director wants to keep his job. It is just a matter of timing and which domino falls first.
Couch- 100% agreement. By the time Pfizer wakes up with their poor leadership and management it will be too late. Nasrat has leverage over the FDA with Puracap and China, the FDAs past written advice, the BE studies, previous past solutions for the Tmax problem, Congress, and the public. Hopefully, the FDA will see the light and approve Sequestox quickly. The FDA in their current position can only Lose! big time most likely ending up with another new FDA Director.
Just Google "bribes" and the "FDA". In the end to wrench ELTP from the fingers of the Chinese Pfizer will pay dearly in the range of 40-50 billion.
China may be as fraudulent as the FDA but the Chinese recognize a great product and a great deal and their is nothing fradulent about ELTP.
I think Lasers observation of moving full speed ahead in China with Puracap leading the way will put ELTP on top of the pain medicine world. China will cut through the ridiculous red tape and see the FDA for what they really are. Stupid! A fraudulent Tmax problem will not stop the Chinese and again they will have taken advantage of OTC manipulation and will end up with an outstanding product, leaving the US fradulent business practices in the dust. America loses again and shoots themselves in the foot. In a Global economy you must be much smarter!!!! Nasrat will win, the FDA will belatedly and shamefully approve Sequestox, but it will be too late in the end. China will gain superior technology over the US again proving again their is more than one way to skin a cat.
The hint of a buyout offer at this stage is a subtle hint that things are going very well at the FDA behind the scenes. The firestorm that I started suggesting generic revenues can support ELTP is certainly coming to fruition with more payments on the way. Looking very good for ELTP.
Thanks, Lasers
I think ELTP should move forward with the Percocet-ANDA. After all, it is far superior to all other ANDAs. Physicians and the market will quickly make ELTPs product#1 whether it has an ADF or not. It means another step forward. Certainly, ELTP will advertise that it is indestructible (so to speak) and future research concerning comparative articles will support this as well. Getting an approval, any approval on any product with the FDA, is a step in the right direction for ELTP. The sooner the better. Once the FDA starts approving ELTP products then psychologically we are a step closer to IR-ADF.
The facts are on ELTPs side. The generics are generating more and more income every quarter. It is just a matter of what kind of nudge the FDA will need to get Sequestox approved. Does Nasrat have to go to Congress or seek additional legal help. The more legally this gets involved the longer it will take. Hopefully, the FDA will come to their senses and the FDA director will realize Nasrat could very very easily get him dismissed and a new FDA director appointed if Nasrat goes to COngress with this. Maybe a little advertising campaign will push the FDA into granting approval. The FDA does not have a legal leg to stand on--none!. Hopefully, Nasrat can come up with a reason for the FDA to approve Sequestox that the FDA director can defend himself against or give BigPharma. In otherwords a face saving way to get the FDA director out of this predicament that the FDA created. Maybe something like" I was not aware that the FDA had previously Ok'd Sequestox Tmax,Cmax issue ( like all other IR products) and back then the FDA felt it was just fine". IF the FDA sticks to their guns- Nasrat can say all IR products must be held to the same standard and all IR products will need to be pulled from the market- a very sticky spot for the FDA- really will piss off Big Pharma then. Nasrat has a lot of leverage he just has to use it in a way to get this approval quickly, allow the FDA a face saving way out, and not upset Big Pharma. Big job for Pfeifer but he is the guy to do this because he knows all the players and he knows why things were done the way the FDA did them. Too bad he could not have been on board sooner.
toofun- The MMs made an absolute killing on this. They are taking wheelbarrows of money home. This was extra money they really did not count on but with this opportunity they pushed the SP down as far as they could go. A new Mercedes in the driveway for free. Bigger profits for them on the way up too. So sad that people got the shaft on this one. Should have been buying, not selling.
As I mentioned before- new generics, approval of Sequestox which includes bonus, and Lincoln, if need be but only over the short term at most. With so many positive factors and ADFs in the pipeline, not worried. But right now the next submission better be ELTPs generic version of Embeda With states authorizing payment for ADFs and the FDA pulling nonADFs from the market it is only a matter of time.
Those additional costs were, of course, research costs. Revenue has been growing quarter by quarter for at least 9 quarters that I can remember. Plus, new generics coming soon. I am not worried at all. We have enough money to submit many ADFs.
jtf3- How could the FDA reject the ELTP generic of Embeda. No need to worry about Tmax and Cmax. Same drugs different coatings. The FDA approved the coating concept and there CRL letter only applies to Sequestox IR and not the ER generics. In this case the ELTP generic will be better than Embeda.
jour-trader- One step at a time. Generics will keep us in good shape.
toofun- Yes, it is a worry that the FDA board members are suppose to be intelligent and informed.
The Tmax controversy will not last long and will in the end be a minor bump in the road. The single most important thing to do now is to keep buying all the ELTP stock you can afford. Continue to average down. I think of this as a golden opportunity made even more golden. This is a real break for those who have dry powder. It is more important just to have the shares in hand. BUy, hold, accumulate. No matter how the MMs have painted the tape, MMs are buying and accumulating more than ever.
The FDA cannot continue to rule out all IR ADFs. Bigpharm and ELT P all have the same issue with Cmax and Tmax. They will have to become more accommodating at some point and more realistic. It may take a joint Bigpharm meeting to work out these levels . Being off by 1 hour - give me a break! Pressure is on the FDA director and if Congress finds out the director is holding up progress on a miniscule issue that everyone has we may end up with a new director soon. It might be a good idea for ELTP to see what other pharmas are doing and approach the FDA as a group . That way ELTP does not look like they are out is step and keep being put in the penalty box.
Hike- Yes, you are correct, of course. ELTP just has to figure out how to very gently without bruising egos and offending anyone convince the FDA board to change their minds. I think having an ADCOM meeting might be an advantage because they will react more rationally about this and realize the FDA itself is splitting hairs. Doing the Adcom is another way of giving the FDA board a way out of what I think is really an embarrassing situation for the FDA. The FDA is on very weak ground as it is. The new FDA director does not want to look bad especially over such an important drug. If the press were to really understand what is going on they would have a field day with the FDA because Sequestox is so good. Much better than anything else on the market. I would also strongly recommend submitting ELTPs generic to Embeda for approval as fast as can be done.
Sixman- First the FDA told us that no additional studies were needed and the data looked good. (which it still does-better than any other ADF). Then we find out there is a labeling issue(easy fix). Then they change their minds and suggest it is a safety issue (BS). Typical government bureaucracy.
Sixman- Legal action against the FDA is the correct direction.
Toofun- I agree. Lets get on the scoreboard with ER because there are no Cmax and Tmax issues. We have essentially the generic for Embeda which should be a slam dunk. Nasrat has to push forward quickly now.
Sharkey- Yes, I agree. All in preparation for a buyout offer. I do not believe this minor FDA glitch will affect the buyout offers. This is because the FDA essentially accepted and passed the our bead technology which is the crown jewel of ELTP. Again it is just the fickle finger of fate that the FDA decided to focus on this issue of Tmax and Cmax. It will be overcome. No drug company except ELTP has the methodology to make Cmax and Tmax match perfectly because ELTP can change the coating thickness on each bead at different narcotic stengths to make this happen. All we really need to do is come within an acceptable range of % of overlap between Cmax and Tmax.
Tmax and IR narcotics is a problem for all IR products from every company. It just happens that the FDA with new leadership has seemingly decided to make this an issue. I am sure Nasrat will be pointing this out by showing similar problems with other current products on the market that have been approved. While the high fat diet/ apple sauce is one approach, ELTP has a great opportunity and advantage over all other companies in that it can change the thickness of the coating around each bead per strength of the drug (5,10,15,20,30 mg,etc) to make Cmax and Tmax coincide.
RLS- I agree. If the FDA knew they were going to issue a CRL they should have brought this issue up a long time ago rather than wait til July 14.
Nasrat needs to be doing four things: 1.start additional quick study for Sequestox for Tmax; 2. submitting the generic for Embeda to the FDA (technically this should be a slam dunk), 3. be in talks with China, Humanwell on selling Sequestox there and in Canada, although in Canada they are pretty much in lock step with the FDA 4. Getting in writing exactly what the FDA needs. I believe Nasrat will address this in a PR soon.
All narcotics are subject to the same problem, not just Sequestox. Ultimately it is the patient's responsibility even though every effort is made to make these drugs as safe as possible. Since 2014, with new guidelines, the new head of the FDA, and new board members, obviously, there will be slight changes to requirements for approval. It is no big deal. Sequestox as a drug is absolutely outstanding. This is a safety labeling problem. If Embeda were going through this process right now they would have the same problems.
The FDA is corrupt. All you have to do is Google "bribes" and the "FDA"
Nasrat will have to be very diplomatic when he initially writes a response to the FDA. He will have to say things like" since board members have changed and since there is a new head at the FDA you may not be aware that in 2014 the fat meal with apple sauce was offered but was not needed in 2014........... but here is a recent one week trial using this method and label changes with outstanding results (we would expect nothing but outstanding results) ........ Are there any other objections or issues that need to be addressed......... then we would like to reapply having addressed the CRL issues. I am not sure how long we would have to wait for the next appointment but I think the FDA "owes" us due to their poor judgement on this issue. If Nasrat took this to the press or made a legal issue the FDA would lose outright and it would be no contest.
Nasrat does not have to wait 30 days to make his next move. Nasrat wanted Sequestox to be FDA approved first because it would have been the only immediate release opiate ADF on the market. That was very smart move considering he spent so much time in communication with the FDA but now only to be blind sided. THe next immediate move would be to submit the ELTP formulation that directly competes with Embeda but as a generic. THe FDA simply cannot reject that because it does the same thing as Embeda which has lready been approved by the FDA. If the FDA rejected our generic to Embeda that would expose the FDA as incompetent and they would have to answer to Congress and most likely a lawsuit. The only difference will be that the ELTP formulation will be better than Embeda. Once that formulation is accepted then it will pave the way for Sequestox, the immediate release formulation with the Tmax issue In the end when all is said and done no time will be lost.
Give us a break. Nasrat was the one who got the letter from the FDA. A safety issue can be a labeling issue. So just exactly which drug, opiates or naltrexone, is the safety issue that is different from Embeda? Nasrat could easily use the results for Embeda for Sequestox even though Sequestox is immediate releae and Embeda is not. The only difference is the quality of the encapsulation or coating with Sequestox being far superior to Embeda. THe FDA letter is really a joke and reflects badly upon the FDA. Even so, Nasrat and ELTP must play the game. Nasrat will meet with them and get the exact requirements needed so they can't move the goal posts again.
MMs are laughing all the way to the bank. Like taking candy from a baby.Hopefully everyone was able to average down at least after buying more.
I think there was a little "piling on " at the open by MMs to accumulate even more shares. I would not be surprised to see naked shorting. MMs will really profit from weak hands soon.
Yes! Lasers- which is why Nasrat will go ahead with the other submissions and stay on track. This is really a quick fix issue with Sequestox.
Toybaby- I seriously doubt the FDA will move the goal posts again. THis was so weak on their part. There could even be backlash towards the FDA for their gross inefficiency.
THis is a great buying opportunity. As I stated over the week end Sequestox will be fine. This is just what Nasrat tried to avoid by staying in contact with the FDA. The FDA should never have managed this the way they did and let things get this far. A total failure of communication by the FDA. Nasrat has related many of the administrative issues have already been fixed and it seems only a minor research issue remains that can quickly be addressed. Anybody, if they take enough medication, even aspirin or water, can overdose. It takes 2 or 3 doses of Naltrexone or Narcan to overcome a Fentynl and Suboxone combined overdose. I have never seen anybody overdose on Naltrexone. I am BUYING as much as I can. In the end this will be an unexpected gift for investors