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With respect to the tMax issue at hand and solving it...
It all depends on how long the tMax is delayed. With Pharmacokinetics, the Absorption component, depends on the following....1) travel time to stomach - negligible unless have a swallowing disorder - 2) disintegration of the capsule or tablet to allow drug to have contact with contents 3) dissolution into the contents of the stomach, 4) permeation/penetration and accompanying transport through the gastric and duodenal mucosa (this is pretty much the end of absorption minus having to reabsorb things that got caught by efflux pumps --but that's starting to delve more into distribution) (also can be complicated further by the ionization of the drug molecule based on the surrounding environment (charged - hydrophilic/water-loving) (uncharged - lipophilic/fat-loving)).
Point of all that above, is.... you remove the barrier - the presumably gelatin capsule - by sprinkling on applesauce on an empty stomach, you not only reduce the time for the capsule to disintegrate in the stomach (which is slowed further with food in stomach), you increase dispersion and surface area to immediately start the dissolution step. Once there, all you have left is absorption. Hence, why this could be a possible solution and past guidance
by the FDA.
Fatty or large meals cause the drug to spend a longer time in the stomach, partially dissolved, and slows travel to the duodenum - where most absorption takes place due the sheer surface area of the intestine- villi/microvilli. Hence the problem with the Absorption-related Tmax delay, or time to reach max drug concentration. Take on an empty stomach, and then there is no food effect, and regular absorption times, albeit minutely slower than the sprinkled route.
Thanks and go ELTP. GLTA. 2017 - The ADTsolute Best Year Ever
My stack continues to snowball...I do not announce my purchases, I follow the charts and their indicators and buy in silence. As much as everyone here rants how charts don't apply, they do. They are very intertwined with the actual properties and catalysts of the company. They both have an effect on the PPS. This then becomes dependent on the value, strength, proximity, and degree of uncertainty towards company related events/reports/technical-indicators.
I will continue to accumulate until we pass my ceiling price, which is unbeknownst to you.
I know what I value the company at using fair standards.
Do you, aside from your insolent banter, know the true value of ELTP?
2017 is our year.
My stack continues to grow...
See the last sentence of the last paragraph I wrote...Empty stomach with whole capsule is fine.
Nice addition to the board. Seem to have a lick of PK knowledge too. Elite's approach to the abuse problem is impeccable. We will prevail, no doubt.
As you can see way back in my post history, my target has always been mid 2017-2018 to cash in. I welcome 2017 with open arms.
ELITE is building inventory, I'm building inventory....let all just keep building, while we have the chance in the dark. We know what we own because we own what we know, dollar plus shares. The public will soon come to know, just after us loyal longs have accrued the shares for the low.
GLTA and may the holidays bring us much joy and prosperity.
He did say we will have an unnamed partner for two products next year, and he did say that he would like to attract buyers. No where did he say there is a buyer right now, only a partner. No reason to be so demeaning, altruism is key as we are on the same side of the playing field bub.
Simple division gives me 14.84 cents?
Don't remember hearing that...havent looked at the transcript, as I was tuned in to the call.
Of course, but that will come with due time. Might I add, that will be the catalyst for an epic move.
Here we go ladies and gents. A monthish remaining. Oh by the way, that CT order, seems to be a partnership for the 2 drugs next year, that nasrat hinted to. He said we have a partner, but did not name them. I'm assuming it will be a big player that we have not seen before. CT order expires right around the time we should hear back from the FDA.
Lot's of catalysts. Go ELTP.
Hey Sharpei and Couch, it looks like we are about to explode. Look at this chart. This should be the start of a very nice movement. MACD about to break into positive with the RSI right at 45/46. Bollinger Bands tightening.
UP we goooo. I think mid-end of this week we start the engines.
The spring is going to expand rapidly, soon. Far too much negative pressure, Bollinger Bands tightening, MACD has been held under 0 for quite some time and it's about to test it again. RSI has plenty of room to run. We break the resistance (RSI and PPS), which with today's volume and great CC could attract attention, then the 10day and 50day will cross and pop we go some more.
thank you ...makes sense
What I have never understood, and hope to hear about this CC, is if this was the poison pill. If that is the case, was it full execution thereof, or just partly executed. Could be a nice foreshadowing of events.
@whoever said this mirrored 2011...the chart mimics the chart back at the end of 2013 IMO.
We will have the quarterly CC sell off... and then Houston, I believe we will have lift off. Mark this post.
My thoughts exactly, except in the fact that believe the CT order and conversion are intertwined. Thanks for the input weezuhl. Always appreciate legitmate thoughts
Very open minded sir. Would like to see your possible negative scenarios, although I'm not sure you have PM. I do not but I believe they still would be visible if you send me one.
I do understand what you are saying, but what options are you thinking? I cannot seem to find any negative scenarios, that would fit the bill, so to speak.
To my knowledge there are only a few things that make sense. Conversion for a buyout, as you would need the shares to be converted to common to get the true valuation and dividends per each share. Conversion for a partnership, for the same reasons as above. Then, thirdly, the conversion to fund the trials needed to respond to the CRL. I do not think the third is a viable option though, as 24 million dollars, far exceeds the small 5 million study that a new BE trial would necessitate. Leaves me with the first two to ponder, but with who?
In addition, why would Nasrat execute his options out of the blue from August 15 to August 21? Exercise of nearly 150 million shares is quite substantial, and I am viewing it as either part of, or they full poison pill that he put in place. On top of the CT order expiring in December, seems to be very telling, does it not?
If that is the case, which I am aware it very well could be, why has the short volume literally fell off almost completely. With no volume, that would be the perfect time to short, because there would be no resistance as they push it down.
Something good is about to happen. Mark this post, and mock me if you'd like, but my thoughts will come to fruition soon enough.
Even if that is the case, we would still be seeing the wash trades with the MMs. No market maker volume=no money for them to go buy some burgers.
They have ruined this stock, but all of a sudden, they are gone. Short volume has also come to a crawl. If no one has interest in the stock, would that not be the best time to short, as there would be no resistance to push it down?
Something is up, and since we aren't spiraling down accompanied by all of the developments that happened as of late, I believe it is going to be something very significantly beneficial to all of us here.
My target for my release from holdings, in this stock has always been 2017, but perhaps I was a bit off target in a very good way.
Ok, to all the nay-sayers, what is your honest opinion on the substantially lower volume all of a sudden? As well as, being stuck in the 16 cent region once again? As I've said before the CT order and the Preferred conversion are very telling of either A) a buyout or B) a substantial partnership. Any other possibilities, I would love to hear. Also, where has Langston, Namtae, and Lowenstein gone? Is that also a coincidence, or something that is also very telling?
We usually have a run up before the CC, with increased volume but this one is quite odd and just hovering around 16 with little to no volume.
All the negative posts about the stock have seemingly come to a crawl, and big posters no where to be found.
GLTA, I'm very intrigued about what is in store for us in the coming days and weeks. Go ELTP!
We do not use Naloxone aka Narcan. We use naltrexone.
Seems quite intriguing as of late, huh? We are back to the 16 cent range once again. Either the MM's love 16 or something is up. Just look at the volume, no one is selling.
MACD about to break into the positive range on the 6 mo chart.
RSI sitting in the upper 40s - low 50's and it just double bottomed today .
Any bit of forward momentum and we will get a beautiful pop.
I sense some nice news coming for us this CC.
Good Luck Longs. We will get there very soon!
* Side Note -- Do not forget we have a CT order expiring in December (I wonder what it is ;) ) *
I mean, I did a quick scan and there was this...I'm sure 21CFR312 has more to say but....
"This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use under which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.”
thanks sharkey1....selectively went through some posts today to avoid the bs and missed your post by accident.
Beautiful article you found there lasers.... and peculiar timing with Barbara's post. Elite trying to drop some breadcrumbs for us here?
Yes sir, just like the fire sale before the run up, end of 2013. Many things to come to light before the end of the year. Mark this post.
Yes sir.
Although, I used to hate AMA's posts over on yahoo before their message boards changed, I am starting to side more with him. It seems this users handle, AMA-ELTP over here on iHub, has validity to it. I am going to have to side with his speculations on the activity as of late.
If the FDA is going to be a complete pain in the arse and bar us from approval in any way possible, then we will sell. Without the validation of our pipeline, Nasrat may not be as happy with the offers, but I doubt we will see less than 1 dollar. I still foresee a 2 dollar buyout, as we have all these generics and a great pipeline. A big pharma would have a much easier time pushing our products through, because our government agencies are all corrupt. Money=Power.
CT order after the CRL, and then preferred --> common conversion following the CT order, seem to point to a buyout or a major partnership. Even the bashers on this board seem to avoid the CT order and conversion topics altogether. Coincidence? I think not. Light is never to be shed on developments that could be of benefit to the company.
Just want to leave this here...
"Considerations
Convertible preferred shares are often issued with poison pill provisions that discourage hostile takeovers and battles for control. Acquirers operate by making offers and purchases for a corporation's total outstanding common shares. Prior to complete ownership, an outsider can effectively control another company through ownership of more than 50 percent of its common stock, because common shares carry voting rights.
Poison pills work by enabling convertible preferred shareholders to exchange their shares for large numbers of common shares, when one investor's stake surpasses a set percentage of the overall outstanding balance of common stock. At that point, you should convert your preferred shares for large investment gains. Overall, the conversion privileges translate into higher amounts of outstanding shares, and increased costs for potential acquirers.
Although convertible preferred shares can be exchanged for common stock, your new common shares cannot be converted back into preferred stock. For that reason, you should be reasonably certain that the company will continue to grow profits and stay in business as a going concern. If not, you should not convert your preferred shares into common stock, and may even consider liquidating the initial principal investment."
In my opinion, and obviously you have more personal data/experience at hand ....If, and that a big IF in my mind, we double bottom, we are going to see a monstrous swing to the upside. I think we will stop before we hit that double bottom though. Once we hit the middle half of October officially, everyone will be having eyes on us once again, since we are to get an update via the CC in early November. Most people, that are aware of our CRL situation, are also aware of when the update will occur.
There is only so much downward pressure they can build. My prediction can be attributed to what I'm seeing on off the Accum/Distr ratio and price levels we hit. They are working harder and harder to push the same margin they did before, and distributed more than when at these levels previously. There is only so much distribution that can occur, since most of the volume has been just to manipulate the P/S down- wash trades, etc. Building the pressure cooker with the tension on the bottom side of the Bollinger Band, too much and we bounce.
What period are you using? I have the 200 SMA up at about 27 cents, give or take.
Side Question for you Sharpei...
I have the RSI sitting at about 31. A reversal is definitely imminent and it is looking like it will be a very strong movement, especially once we cross the 50 day MA at around .175.
Could the next couple of days be the start of another coordinated run up ?
I also think that the premise of ag-antag abuse deterrence, will become multi-modal, and become the mainstay for any drug that can be abused.
Think about it, "Pfizer/Purdue/etc. caring for the addicted by forgoing any medication, that has potential for abuse, that is not in fact inherently abuse deterrent". That is a play I see big pharma capitalizing on for sure. All the while their money, their real motive, is stacking up in the background. Hidden by the guise of suppose "care-for-the-population" movement, from the "new" brand name drugs, tailored to current US addiction problems Big Pharma will grow.
We will be apart of that growth, either directly, through independent marketing and sales, or the more likely, indirectly, through an acquirer intending to use our pipeline and technology.
Just you wait and see. ELTP is good to go. The FDA is just walling off/barring approvals for IR Abuse Deterrents, until they have enough comparator data and viable market place competitors.
Yes, and I would as well. But as with everything nowadays, it is controlled by our Senate and House, who can serve infinite terms. If you never, or even rarely, get anyone new personnel in office how are things supposed to change. Usually, they won't. Even the president can only do so much, if they have fierce opposition by Congress. And changing a few congressmen here and there, will never really alter the balance in the Senate significantly. Hence, why we see a dominant party take over, for some time, before it slowly flips 180*.
So 'we', America, decide it's better sit right on our golden thumbs, while idly watching millions fall into the downward-spiral of a disease known as Addiction, rather than to take action with a 'state of the art' approach to abuse. One, that in fact, does not physically harm the abuser if attempted.
In fact, if formulations like Elites (not even just Elite) were out, it would be a deterrent in itself. Addicts would now have to cover insurmountable sums of money to get a similar high and rush orally (although it will never be reached to the same degree as it has much to do with abruptness of onset), compared to what they had to "shell-out" for their non-abuse deterrent/resistant, and usually generic drugs. As we all know, Brand Name drugs are much more expensive (although this gap is tightening with less and less generic competition), and attempting to feed an addiction with a 'state of the art' brand name drug, will simply not be sustainable.
As far as I am concerned, when SequestOx is approved (and it will, even if we experience another unforeseen delay), it will serve as an Abuse Deterrence in two respects. Inherent to its formulation-bead encapsulation technology- and to its sheer price, once on the market.
We will persevere. In the background, we just keep on building, with respect to many fronts.
It's not the sole property of the formulation that is causing the delayed Tmax, it is the drug's properties itself. Of course, dissolution of the matrix-bead must occur first (which can be altered by food effect) but the drug itself is also interacts with the food. Hence, why so many opioids on the market today have a label about taking with food.
Otherwise, good, seemingly impartial post. Although I may not agree with some of it, I do like the point of view.
Thanks Kayak. Keep on, Keepin' on.
I believe it should be a little less biased, with respect to the naming conventions, towards who you are trying to throw under the bus haha. Although, what you say is the truth, unless you get a rinky-dink news station to do coverage on it, the government has influence. A story like that would be gold to a news station, if balanced in the right way, for it to not effect the political workings of our government.
Yes, just bought some more after seeing that, even though I said I was done yesterday. That's a crazy big order, bigger than cumulative volume for the past 9-10 days. Follow the moolah.
Or they are interested in paying a lower value than Nasrat wants.
740 mil isn't fair value for ELITE. Although that is a large sum of money to us, to them its just some bronze-grade lube, to grease the gears that 'keep them a churnin' out profits.
Yes, it can be applied to that instance as well. Anticipation drives momentum. Yes it was negative news, but hell do I care. My time frame to sell my position or to be bought out, still remains set in stone for end of 2017/early 2018. Logical time frames must always be assessed for major developments like approval of our Sequest. Yes, I did believe it was going to be approved the first time around (due to its priority designation) but the FDA is biased towards, and gives their ear to, Big Pharma and its lobbyists.
I do believe our chances of approval have now increased though, and fatty/large meal effects can be seen across multiple drug classes and seen quite frequently with opioids. This is nothing new to this class of drugs. However, Nasrat was told we would not need this data originally, but the FDA did a back-flip and then re-required it. We will solve it.
A quick and cheap study will -render that box-, that the FDA threw in our face, checked and accounted for.
Remember, as I have stated many times before, the confidential treatment order expiring in December. I have a couple well educated hypotheses of what the outcome of that document could be, mostly all positive, with a few neutrals sprinkled in. Either way, we have news coming our way, and my bet is on Green.
Can anybody say Cup and Handle?
News this week will definitely finish the cup, then retrace and consolidate, then soar to new 52 week highs. SEC audit will be finished by the end of this week. Good luck to you all here. Just finished adding to my position, since I cleared some funds yesterday, and now I have a nice base. Have been holding for a few months now, but have had minor eyes on this stock for about 1.5-2 years now.