Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
14th makes more sense. That's a wednesday. #winningwednesday
I expect earnings next week with CC to follow.
ELTP 10-K's over the last few years:
2016- June 15
2015- June 15
2014- June 30
2013- June 21
2012- June 29
...Amarantus progress on fulfillment and CHF evaluation of the ongoing negotiation with all parties is all that really matters on June 25...
you keep saying LOI withdrawl. Did you not agree with me that it's unlikely LOI is just poof, done, gone, terminated june 25? I thought reasoning and historic precedence was relevant here. While possible, it's unlikely with talks ongoing.
JP, I think chances are low the LOI gets cancelled on or immediately around the deadline. And I doubt we would hear immediately one way or the other.
Number 1, as you understand, if this doesn't work out (and assuming there's no other path, we are quickly headed for the chopper and some form of protected restructuring where common dies. Seeing as that's the case and no party wants to appear cut throat in front of the courts, as I've seen before, the LOI will be extended several times to show due effort by all parties to achieve a better outcome. This in fact may have been the plan since the beginning. CHF is a sophisticated investor. He knows to do DD, and knows how to achieve a sophisticated outcome even if the deal falls through. Same with Magna et al.
No 2, we all understand this is complex with many parties involved playing games of chicken. Some of it I'm sure has gotten quite personal, though in the end enough money to win or lose will mean money talks in decision making. Time must be given for all parties to determine their outlets and what options are strong, or exhausted. The LOI may very well be extended as some parties capitulate at the very end, or come up with odd terms that need to be evaluated by all parties again. Fact is, if progress is being made, or parties are still talking, there is no reason to end a deal that has required so much effort simply because an ultimately arbitrary deadline was set to achieve something. CHF set the deadline to trigger a new set of pressures on parties. After June 25, the only thing that changes is the game. Now all parties are under direct threat of an uncontrollable outcome if CHF pulls the plug. Right now, the incentive is to posture, not put down signatures.
I expect this to bleed into early autumn before a final outcome is known. And you may very well be right, as LOIs get extended and credit issues become more uncertain, we may track lower indeed. There's no buying pressure in such a case.
aelmtpa, I would imagine percocet is they type of medication the FDA wants to take longer than 10 months to review. But thanks for reminding us of the odds.
Thanks Jour. I think that will be true for some of the population, but the problem now, specifically with fentanyl, is that dealers are sliding it into the hands of people hooked on oxy like there's no difference. #1 having ADT opiods would mean less people get started in the first place, but #2, if and when a clear divide emerges again between pills being able to get you high or not, it will be clear that either A) this pill shouldn't be taken, or B) if it's the main pill being dispersed, people will not conflate how to get high off them. OR when they're high, they won't go looking for greens and blueies and grab the wrong little blue one. I think that's how these happen a lot. Confusion. People are usually decent at using drugs. These spiked numbers are coming from a continually growing population of new addicts and confusion in administration. Figuring out how to get people to go from addicted to something other than fentantyl or heroine is certainly another problem. 1) weed dicriminalization, 2) kratom 3) cigs 4) education and opportunity 5) investment in rehab 6) stop the heroine flow
My buddy in KC died last night. We think fentanyl. My history with oxy's really set me back and got me started on this investment. Another guy I know and a brother of one of my friends died in just the last month. This is such a problem. Whether our investment works out or not, we investing in trying to make a better future, a meaningful one where lives are saved, not just in a better sandwich shop, or some fancier phones.
winning wednesday. Haven't sweat a bead. will start sweating a little if no news tomorrow. Perfectly reasonable to not expect news tomorrow, but it's a wednesday and it's the 17th, highly likely they got results this evening, had a meeting, and will have PR in morning
Winning Wednesday
I relistened to the Feb 13 CC. Nasrat says the following: "The path is as follows... complete a fed BE study to demonstrate the modification is successful. If the fed is successful, we will then complete the combined fasted BE and dose proportionality.
The other work required to be done includes a category 1 in vitro lab work and stability study.
"We think we can... resubmit by years end."
Question for the serious. What is the tradeoff with the modified formulation? Obviously, we can change the formula, the capsule, and various mediums to change the Tmax time. But something else has to change. They had three modifications on hand to solve the issue they may have identified as early as fall 2014 (no time on X-axis) and must have known might be an issue as of fall 2015 with Aviridii outcome. Logic suggests these reformulations must have shortfall/tradeoff or would have been the original formula. Some might be chemical, affecting performance or safety, and some might be costs to the bottom line, it's pure speculation either way, but there's something. Point is, assuming there is a tradeoff with the change, what do we imagine it might be and could it affect the second set of tests? I mean to suggest that it is possible we can achieve success on this fed BE but increase our chance of failure on the second set of tests. We're not out of the woods even if, hopefully, we get good news in the next few weeks.
bouncing off an upturned 50? been awhile...
According to court filings on SCROLL Sason, Magna et al. are under federal investigation by the SEC. This may explain the last year and a half of oddity. It would also suggest dilution remains off the table, and silence ought to continue.
How do companies who have been illegally diluted unfold from criminal activity? You can't cancel the shares no longer possessed by the criminal parties. But of course, it might cancel the debt, overhang, and monkey on our backs. It's blatantly obvious wrongdoing has occurred. The question is how far will the SEC be able to go and on what time frame. Hammer or slap on the wrist? And is the company a victim or party to the scheme as well.
good and bad. Clearly we prepared for the coming winter. Hard not to see a squeeze and slashed R&D. I'm sure that has changed now. All focus back on sequestox.
Need to know why our margins are getting squeezed. In the future, without a substantially differentiated product, $100mill in revenue won't happen if we're packing dust for 10% off the top.
Trump met with Sheriffs from across the country today and the very first thing he mentioned to help with crime and the opioid epidemic was expanding access to abuse-deterring drugs, which he said were new and people weren't talking about enough. You can watch the meeting on youtube. GL
oh, i made it up
Orrrrrrr, maybe it's the print publication date
In other MANF news
"Mesencephalic astrocyte-derived neurotrophic factor alleviated 6-OHDA-induced cell damage via ROS-AMPK/mTOR mediated autophagic inhibition"
http://www.sciencedirect.com/science/article/...6516305575
Experimental Gerontology
Volume 89, March 2017, Pages 45–56
Quote:
Abstract
Autophagy and apoptosis are commonly involved in the dopaminergic neuron damage in the pathogenesis of Parkinson's disease. Recently, the autophagy pathway is thought to be critical to the process of PD. Therefore, the regulation of autophagy may be a potential strategy for PD treatment. Mesencephalic astrocyte-derived neurotrophic factor (MANF) has been reported to have neuroprotective effects through anti-apoptosis, anti-oxidative, and anti-inflammatory mechanisms in PD. In this study, we investigated the role of autophagy system in MANF-mediated neuroprotection against 6-hydroxydopamine (6-OHDA)-induced neurotoxicity. Our results showed that MANF protected SH-SY5Y cells against 6-OHDA-induced cell viability decrease and apoptosis by inhibiting autophagy. Mitochondrion damage and energetic dysfunction triggered by reactive oxidative stress (ROS) accumulation were also alleviated by MANF treatment. Furthermore, MANF downregulated phosphorylation of AMP-activated protein kinase (AMPK), a cellular energy sensor and regulator, but upregulated phosphorylation of Mammalian target of rapamycin (mTOR) under energy depletion conditions, indicating AMPK/mTOR signaling pathway is involved in the autophagic inhibition of MANF. These results suggest that autophagic inhibition provides protective mechanism of MANF in 6-OHDA-induced SH-SY5Y cell death and this inhibition is associated with AMPK/mTOR pathway.
I can agree that's its important to get this first one right and it shows Nasrat's wisdom in doing these one at a time. I mean is and when we do get this to market, the others will be near guarantees and everythin will move faster.
this is not good news on any level. we already knew we had a clear path forward. this is on the more difficult and risky end of those options. There will be time to set up the studies, time to perform, time to collect the data, time to put together resubmission, time for the review. All in all, this is yet another yearish delay if not longer. The FDA drives me crazy. All we have to look forward to are surprises that may come along in the meantime from all the coals we have in the fire.
from the FDA:
Comparability Bridging Study: A study performed to provide nonclinical or clinical data that
allows extrapolation of the existing data from the drug product produced by the current process
to the drug product from the changed process.
I don't think they're going to release the transcript in its entirety and I think they'll want to talk about it, especially if its anything clear but not straightforward. But I agree they may just wait for the February call too, so easy to do, and they'll likely be closer to an endpoint then as well. But the company knows we're anxious and that the 30 days is up. Business update calls are not uncommon.
I reckon Wednesday CC announced tomorrow.
But hey, until the fat lady sings, nothing matters. The FDA gave us a "clear" path back in 2015 too. Sheisters. All ELTP can do is do what they're assigned successfully. Could be they'll already have results for us tomorrow and resubmission imminent.
Mocha, true, but most of them are referring to FDA "rules" (more like guidelines anyway) that say FDA will deliver meeting minutes within 30 days of meeting.
No mention of upcoming launches, I did not ask. Simply that they're looking forward to revenues increasing substantially and looking forward to these ANDAs being approved pretty quickly these days. It was a brief call <5minutes, mainly to clarify what 3rd week meant since some people on the board may have ants in their pants.
well, the part in quotations for one ;) For all of it, you'll just have to take my word for it that I accurately described what she said to me. I physically picked up my phone and called her at 1045EST today.
GL
Well, namtae, I called Dianne.
As always, she was very pleasant. As expected, she told me the third week in December meant next week, and it is still happening. "the least likely" outcome of that meeting is that the FDA rejects their proposals. We may, but should not expect to hear anything from the company next week. Just as any corporation would, they will likely wait for the response and meeting minutes in writing and then they will release news as a decision is made how to proceed based off the FDA's response.
Nasrat said they would know the third week of December and they will. We may not know until later.
She also had good things to report about the roll out of generics. I congratulated her on the ANDA. They are very excited for the future.
Still no word around about when Pfizer plans to launch.
Does anyone have enough legal experience to comment on the discovery efforts by Mr. Snyder so far? Specifically regarding the court orders/transcripts on SCROLL for Oct 4?
I raise my glass to you, that is some of the best DD I've ever seen on Elite.
honest question, I'm tool azy to look it up, but what's the turn around time on the Perc ANDA. Was any guidance given? I don't recall, and yes I know nothing is ever concrete, so I could understand if nothing was said.
Couch, please, of course they don't have to, they don't owe us, and I have no idea but I doubt others do unprodded (I wouldn't know, and how often are others in this situation anyway) but that's what the nearly the entire elite investment community is hung up on right now. Especially if they're talking about additional, albeit minimal dilution, disclosure would be helpful and beneficial to all.
You like to put the onus on others. Give me one good reason why they shouldn't disclose TMax data? Give me one good reason why I shouldn't get an email back, even politely saying they choose not to disclose at this time, after repeated inquiries. ya know, don't even bother responding. It's not necessary, right?
OK woah, correction.
He said he had run a variety, or several or something to that effect studies which will be useful to present to the FDA.
He specifically said they would present three options/plans to the FDA.
The way you phrase it makes it seem like all the prep work and proof for those three studies is complete.
I think very specifically there is work to do after they meet with the FDA depending on which plan the FDA chooses and whatever else they might add, if anything.
Couch, you know me to be long. But I am disheartened I continue to be stonewalled by the company via email and again here on the conference call. I cannot imagine the excuse at this point for not providing us shareholders what the Tmax values are for SequestOx. They won't even answer questions like what effect they suspect sprinkling could have on that delay time.
I think it's very fair to know if the Tmax delay is even in the same ballpark. I don't understand why it wouldn't be, but we deserve to know. I'm coming to the conclusion that the time gap cannot be bridged, but that we will indeed have to rely on some personal relationship building between our new board member and the FDA. Otherwise why not share the data!!!
well, his shares are worth dick now, so we have that
did you catch that appendix A?
and the R/S isn't proportional?
And magna has 160 million left to convert?
mmmm shame
fins next week, CC could be the following week
Let's make sure the company gives us comments about these divestitures on the CC, very exciting
jesus couch, I can only hope LPC 2 is tapped out. Don't want to go much lower, that's just less money for the shares.
back of the napkin math says LPC 2 is about 1/2 complete. Hard to say. I hope they wait to exercise more, as at some point they endanger their ability to see returns, but I think more pain is ahead.
Still nothing worth talking about til we hear from the company hopefully on the Aug CC.
Any of you who think you know "better" than FDA now that they've made themselves clear are crazy. We're all here to make money in the end and the short to medium term is very cloudy til then.
My advice, have a pint and wait til this all blows over.
elichen, "the drug's requirement to be taken on an empty stomach would be too complicated for patients to manage"
this is not the same condition. sequestox is BE in every way under fed conditions. we're worried about the small chance its taken around a fatty meal.
to further distinguish the two, sequestox has a readily available remedy for the label in that it can be sprinkled as a capsule. the other is a tablet, leaving patients in pain with a) no remedy b) several times a day when any food is consumed.
sequestox has a) a historically relied upon remedy to b) a problem that only occurs was far less frequency
further, see the panelists comments about weighing benefits and risks, so our decreased risk matter.
your post is misleading/incomplete. There's a reason capsules exist, and sprinkling is a common FDA approved label for precisely these purposes. Capsules themselves delay release typically around 30min. Usually in IR capsules these are gelatin capsules.
roxicode data on AUC, Cmax, Tmax for different doses can be found on websites like rx list
" In addition, food caused a delay in Tmax (1.25 to 2.54 hour)
so you can see, decreasing SequestOx Tmax by 30min could have a significant impact on establishing, as 505b2 stipulates "reasonable similarity."
I will try to learn more about what capsules we use and what the existing data is.
we're 3 weeks from the typical Q1 CC. This will also be just shy of a month since receipt of the CRL.
I imagine we will hear that they have met with the FDA, made a proposal, and are awaiting a response by then. I expect they will cautiously plan for failure, and as such, we will not know the result of the meeting until we are ready to submit our next application, suggested to be this quarter. So my expectation is by end of September we either know CRL is the end and we're submitting next application, or we know we've got a shot and we're launching pk/be and submitting next app
I've been in correspondence with the company to try and discern why we'll overcome this safety issue when Purdue's Aviridi could not.
It appears, by the grace of God (and seasoned foresight) our capsule design will save us as Aviridi was a tablet that could not change Tmax, even with labeling, and of course nothing could change the Cmax. In addition, of course Aviridi's bioequivalence being souly in unfed conditions made anything but a safety issue.
Having an easily opened capsule should make our direction easy and upon presentation of additional evidence, and or trial,make this a labeling issue as the FDA originally indicated. In total, while we'll be unable to remove all unsafe conditions, the experts weighing benefits to disadvantages will be looking at a far superior technology.
how long is our Tmax delayed on fatty?