Sunday, January 29, 2017

ELTP needs movement

it's difficult to make a buck in the pharma industry these days.  the internet has turned the stock market into a deadly vicious uncaring death pool waiting for you to be tempted to take a dip.  elite pharmaceuticals has been disappointing during the last 12 months, but it is not for apparent bad leadership.  obviously, Hakim made forecasts and did it in a bold, confident manner.  the FDA made him eat his words but thankfully Hakim stays positive without letting delays and rejection skew his path.  but it is so quiet lately, and the movement on the share price has been disappointing despite progress with the pipeline. 

here is a sample of posts from the day:

from: Inthe203  
HERE IS ONE ISSUE WITH THIS DRUG

CLINICAL TRIAL ISSUE:

With a fatty diet and the consumption of one pill, the patient had the sense that the drug wasn't 'kicking in' or effectively working. The patient will then take ANOTHER ONE or even a THIRD and still not receive the maximum effect of that first pill taken. IN THE MEANTIME, now three pills are consumed and the patient is now in jeopardy of an actual overdose without realizing it.

THIS IS WHY the FDA denied the approval.

THE FDA also clearly stated in their response that putting a WARNING LABEL on the bottle will NOT suffice, which poses a HUGE problem for ELTP.

There's no conceivable way around this issue. This is ONE of prominent loopholes ELTP is struggling with and unless the company is physically present to tell the consumer to watch their eating habits, this simply isn't going to end well.

As an investor, i'm extremely disappointed. I'm guilty of putting all my eggs in one basket (just shy of 7M shares) and i'm stuck holding the bag.

I'm looking for a miracle and NO ONE can challenge me on this. I'm simply telling you factual information that came out of the mouth of the FDA!

$ELTP$ 


by:  WeeZuhl
40,000 ER docs in the U.S. with at least as many NP/PA's working in the ED, probably a lot more. Approx 80,000 E.R. providers.

Now add in Urgent Care. 10,000 urgent care clinics in the U.S. Each clinic probably has an average four docs and as many NP/PA's, so we'll approximate another 80,000 urgent care providers.

Approximately 160,000 E.R. and urgent care providers in the U.S.. We convince just 10% to switch to SequestOx, and they write an average of one script per shift- about 20 scripts in a month of 20 pills each.

160,000 x 10% = 16,000

16,000 x 20 scripts x 20 pills x 12 months = 76,800,000 capsules per year.

Now set your price. Say $5/capsule (approx. 5x of generic oxy capsules).

76,800,000 capsules x $5/cap = $384,000,000 / year in revenue just from 10% of ER and urgent care providers writing 1 SequestOx #20 script per shift.

Now what happens if you get buy-in from 25% of the those providers? 50%? Now start to add in pain management, primary care, and orthopedics. 

by: aELmTPa  
The modified formula is already complete and trials have started comparing the new formula to the old one.

Elite will proceed immediately to complete in vitro and in vivo bridging studies required and expects to resubmit the SequestOxTM application later this year. The in vivo studies include bioequivalence and bioavailability fed and fasted studies comparing the modified formulation to the original formulation.

the modified formulation

the modified formulation

the modified formulation
 

3 comments:

  1. Interesting enough a generic version of Subutex which is buprenorphine w/o naltx...well a friend receives his from am local pharmacy 'walgreens' and instead of using the orange 3rd party medication bottles it was still in the factory sealed bottle with his info on the walgreens sticker slapped over the factory label but hears the catch. A huge piece of paper folded down to a 3/4"x1"x3/4" taped to the upper curve towards the cap(I would think since it was factory instructions not all the walgreens paper work this made for easier stacking in a box as thats the only empty/dead space at the curve towards the top to the lid to put something like this along with the container w/o *re-opening it.) Now I asked whats that, he did not know as he said they dont usually give me this white bottle. I open the paper and drum roll pleaseeeeeeeeeeeee T-max levels amounts/times/all graphed as per mg...! Ha, I laughed to myself because i dont think any of this would of even been there if it werent for Nasrat. Someone in my Opinion, which i get one or two for fairness:-), either already knew this was never checked under a microscope as just compared/checked but behind closed doors in which it may have had to meet some easier brackets/say 'ballpark' levels and never seen as needed to be public knowledge to the user and wanted to slow or speed bump Elite by passing on well did they check the T-Max level and this could of been the start of a new regulation in which in the long run may blow up in this persons face. So now you have this new questionm...well whats the t-max...does anyone know the t-max kinda reminds me of gluten when did people start caring and where did it come from? Anyway this may have slowed things down while they're going through the steps of finishing there product OR since this medication has it already attached to the outside side 'scotch taped on' not inside the foil factory seal is this the change of medications standards of controlled substances or all? for the user to be aware not only beyond pharmacist warnings and doctors warnings ect and

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  2. what kinda dumb luck it started with a company(elite) we all picked that's actually going to inform the medicated of the way there pill works and leave all liability for our company and others to the user and now makes it no ones fault but the patient's with the actual blood levels and testing results/tmax levels/times/mg's blahhhh in the paper work attached to the bottle in which still sounds like someone speed bumped us....BUT ALSO SOUNDS LIKE EVERYTHING I READ ABOVE IS VERY TRUE AND UNLESS THEY CAN PROVE THERE LEVELS..WELL I'M ASSUMING EITHER WE INVEST IN SCOTCH TAPE FOR ALL THE NEWER DRUGS THAT MAY HAVE THIS INFO ON FILE OR ALL OTHERS WILL BE HELD TO THIS STANDARD EVENTUALLY AND IF IT NEED BE SO, WERE GOING TO SEE SOME INSTANTLY FALL OFF THE SELF AS SOMEONE ELSE WITH MORE KNOWLEDGE OF WHAT YOUR TAKING IS PUT IN YOUR SPOT-SHOULD BE INTERESTING. WEEZUHL HAS DONE SOME OUTSTANDING RESEARCH AND I WOULD OF NEVER OF EVEN BEEN INTERESTED IF IT WERENT FOR ELITE IN WHAT WAS ON THE SCOTCH TAPED PIECE OF PAPER UNTIL I INVESTED INTO ELITE YEARS AGO AND READ THIS AND THOUGHT I HAD HEARD SOMETHING CLOSE TO THIS BEFORE THE RIGHT UP THEN I SEE IT RIGJT IN FRONT OF ME. I COMMENTED A+ before when I read it, A+ again. If you would like to see the piece of paper heres where it gets very funny go to our CEO OLD COMPANYS SITE. YUP ACTAVIS HA AA THATS WHO HAD THERE T-MAX PAPER WORK READY. SMALL WORLD RIGHT? MAYBE A LITTLE HARD FEELINGS ABOUT ONE OF YOUR HIGH UPS LEAVING? I would like to know are any other medications coming with these t-max levels and graphs attached to the factory bottle? Or was the speed bump from the Ceo's ex love which would really but that fire under him in my third opinion. Something to think about as we'll all never really know. Please mod of this would board feel free to email or forward any info anyone donates on how long has this been happening, what actual med and brands have to have it? All that fun stuff to me, this is REALLY interesting. (did he know of elite having this while he was at actavis? they wouldnt sell out to actavis at the time did that make him leave and start his own company? then work his way into ELITES heart lol to show his old company I'm smarter then you took me for? Lol love it. Or it could all been dumb luck...sorry for any typos as I'm using a cell to type this.

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  3. Hey there! Leakedout, I have to say that's one of the best comments I've ever received on this here blog, interesting information. Thanks for sharing, you're always welcomed here. Nasrat, genius or kook? (Or something somewhere in between...) We will have to wait and see. I'm rooting for genius.

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