in fact, here is a relevant post from three years ago...
"meifud • Aug 22, 2013 12:43 PM
hakim also has incentive. he sold that baker's dozen of drugs to elite for $10 million (140 million shares at .07) with the payment due in three years. so he put himself in charge (salary of four million shares per year) to make sure he gets paid. quickly brought over dougie to further solidify his control and assure the job will get done. hakim has the connections, the know how, and the will. everyone needs to at least give him the benefit of the doubt because he would not have done this if he did not expect to be paid."
he's been here three years and has never sold a share or taken a penny in salary
clearly, he is holding for better days
he has also bought shares on the open market and put them in a trust fund
yes, of course they have more than enough money but when you are replying to bilie you have to picture banjo boy from Deliverance and 'taylor' your message so as not to make fun of someone who is less fortunate -- keep the kiss in the middle
Hakim was given rights to those shares when he took over in August of 2013 -- he had three years to either convert the rights into shares (at the then current price of .07 per share) or receive $10 million cash. he opted to convert into equivalent preferred shares in February (i think) of 2014. not sure why he didn't just take the common then, but it looks like he still had to convert into common on the third anniversary of him taking over
those rights supposedly represented payment for the 'baker's dozen' of drugs Hakim brought with him from Mikah but i suspect it was also, in part, a signing bonus
the studies required by FDA earlier this year were just that -- quick, easy, and cheap -- and they included an efficacy trial, a stability study, and a labeling study
all that is left is a straight forward short term food study which could result in 'sprinkle on food' instructions -- same as was done for xtampza
Hakim will deliver options to FDA, then FDA selects a preferred option, and the study will get done over about eight weeks, same as the efficacy trial
there is no great cost involved, and Elite has the strongest cash balance in its history, so it should hardly cause a ripple in the balance sheet
its for each person to send or give to their own Representative
best to hand deliver to them or one of the staffers in their District Office
my Representative has two offices back home, in addition to the Washington Office, so i delivered to the nearest office and discussed the matter with the staffer
hopefully, your Representative will forward your letter to the FDA asking for response to the issues raised by their constituent so the Representative can keep you informed
part 2 of 2
already been done, FDA said it was for determining what should go on the label with respect to taking it with or without food. Note: FDA was fully aware the previous BE had shown that SequestOx's release was delayed if taken with a large meal -- but FDA did NOT ask for a study to address that, and FDA did NOT raise any safety concerns when identifying needed studies.
Well, the new BE confirmed that a large meal slows the release of SequestOx, but all of a sudden that has become a safety concern for the FDA. Why? Many other drugs of all kinds behave differently under fasting or fedl conditions, but such differences are routinely addressed by label instructions. In fact, Extampza, an extended release oxycodone, was only recently approved with instructions telling patients to actually open capsules and sprinkle on food! But for SequestOx, FDA suddenly decides that patients can no longer be trusted to follow label instructions? Why?
To summarize, prescription opioids are relied upon by many patients but they pose a problem in that they are sought after as street drugs. SequestOx would effectively address this problem by blocking the euphoria addicts seek via snorting or injecting. By not acting in good faith and in denying approval of SequestOx, the FDA is acting contrary to the interest of patients, police, the Courts, addicts, and treatment facilities.
I ask you request FDA to reconsider and approve SequestOx as submitted by simply requiring appropriate instructions be placed on the label with respect to taking with food, which FDA has alreaady done for many drugs. If FDA decides this can only be done following further studies, then please request FDA to work much closer with Elite than was the case in 2014, to ensure the studies answer all of FDA's concerns as efficiently and expeditiously as possible.
I am writing to request your assistance in a matter of considerable importance in fighting the heroin epidemic and in addressing the alarming rise in drug addiction. Specifically, the FDA is denying approval of what would be the first ever immediate release abuse resistant pain relief drug – a drug that could be prescribed by doctors without risk of it becoming a street drug or being used by addicts as an alternative to heroin.
The drug is SequestOx, a combination of oxycodone and naltrexone. Oxycodone is the most widely prescribed drug for relieving breakthrough pain, but is extensively abused and is considered interchangeable with heroin. Naltrexone is used to counter the effects of heroin and other opioids such as oxycodone. Elite Pharmaceuticals has developed a technique for combining these drugs in a way that provides pain relief when taken as directed but which blocks the euphoric high an abuser would seek by crushing the pills for snorting or injecting.
Elite Pharmaceuticals worked closely with FDA prior to submitting SequestOx for approval, and even received priority review status -- but FDA blindsided Elite and is now requiring additional studies over a minor issue that was known by all parties beforehand and that was supposed to be addressed through simple instructions on the label. That is the way it has been routinely handled for many other drugs.
Specifically, Elite met with FDA in November 2014 to go over all the studies and trials that had been done for SequestOx to determine if FDA wanted anything else before submitting it for approval. FDA specified three short studies including a bioequivalance (BE) study. Asked why a BE study was needed when one had
end of part 1 of 2
"As of June 30, 2016, the Company had cash on hand of $12,814,951 and a working capital surplus of $13,607,755. We believe that such resources, combined with the Company’s access to the remaining $18.1 million available pursuant to the $40 million equity line with Lincoln Park is sufficient to fund operations through the current operating cycle."
last quarter, Elite reported over $500k profit AFTER fully covering R&D expenses
Elite might even cover R&D from operations in the quarter being reported this week
if this pattern continues, there will no need to sell any more shares to Lincoln
reminds me of a senior friend who once called asking for my number because he couldn't find it
anyhow, try cutting and pasting this, then book mark it a few times because it doesn't always work, and then share it with folks whom you haven't been seeing on the board and would like to...
as you have said many times, pps for an OTTCBB listed stock reflects market manipulation and little else until a company produces an irresistible and irrefutable product -- just such a product is SequestOx
though oxy abuse has become an epidemic, it remains the go to drug for breakthrough pain -- hence, the multi-billion market
and though no drug is resistant to oral abuse (taking too many), doctors can prescribe SequestOx confident they will not be contributing to the street market for snorting and injecting
have to think the request for a meeting has already been made, and should be held by end of August at the latest is FDA follows its guidelines for NDA's that have received CRL's...
"Type A meetings should be scheduled to occur within 30 days of FDA receipt of a written meeting request."
FDA was briefed on all the results of studies done in support of SequestOx, including this Tmax issue, when Elite met with them in November and answered all questions. FDA subsequently accepted SequestOx for review and asked only for a labeling study rather than another BE trial to address the Tmax/food issue
the results of the labeling study simply confirmed what FDA already knew in November, e.g., that taking with food needed to be addressed on the label. again, that was already understood by all parties
but the Complete Response Letter completely ignored that understanding, and the FDA is acting as if the issue is all news to them. if Hakim sounded a bit upset on the conference call, that is why
well, unless FDA's SequestOx reviewer was not aware of the November meeting, or was reassigned and not involved in writing the CRL, FDA has some explaining to do when Hakim next meets with them
and, that is why you should consider contacting your rep in Congress and letting them know the FDA is holding up an abuse resistant immediate release oxy that has no value as an illegal street drug
"The options are: Changing the drug class from IR to ER"
don't know what the ELI-number is, but that formulation is already one of the drugs in Elite's pipeline. Hakim will certainly give priority to moving that one through, while continuing to work on getting SequestOx approved
" the market for Oxycodone for the IR space is roughly 5.5Bn and the ER is about 6Bn"
think the number is $8 billion for immediate release, and $2.5 billion for extended release but i've seen bigger numbers for both. the IR market is waiting for its first abuse resistant entry, while the ER market already has five abuse resistant alternatives, though all have weaknesses that are limiting sales. in fact, if a good abuse resistant formulation were to enter the ER market there is good chance that market would significantly grow
bottom line is just what you have said -- notwithstanding a labeling issue that has to worked through, there is a lot of opportunity and options for Elite going forward now that FDA has blessed their patented technology
the FDA response to an NDA is a COMPLETE response letter, which means they have reviewed everything submitted up, down, front, back, upside down and inside out, and they are telling the applicant absolutely everything that stands in the way of approval
and the ONLY concern the FDA identified was a minor issue involved a labeling issue which has been routinely addressed for many, many other drugs by simply adding instructions to the label explaining whether to take the drug with or without food
no big deal, just a temporary delay, another bump in the road that can be expected though not predicted when dealing with the FDA, and SequestOx will
HOWEVER, there is something of great significance to shareholders contained in FDA's response because FDA has in fact confirmed not only that SequestOx can be approved but that all of Elite's pipeline using the same two-bead approach will also receive approval
just consider what has happened -- FDA performed a complete, inclusive, comprehensive review of SequestOx, and could find NO problem whatever with any aspect of Elite's two-bead pharmacological ABUSE RESISTANT technology. yes, FDA accepted the Human Liability Studies along with the safety and efficacy studies. in fact, if SequestOx had been an Extended Release (the formulation for which is already in Elite's pipeline) instead of an Immediate Release it would already be approved
folks, this is huge! the FDA has confirmed Elite's technology by NOT identifying it as an issue in their Complete Response Letter. and that means Hakim is right -- nothing can stop us. there may be a few bumps to get over and potholes to get around, but nothing can stop us
every situation is different and there are no controlling regulations. the CRL gave Elite one year to respond but Hakim will certainly move as quickly as possible to meet with FDA and determine best path forward
conference call coming up in three weeks. send questions to Dianne for the Q&A portion. if you do it now, it's possible you get a personalized response before the CC, but probably not
don't know if you listened to the call on Monday, but two things stood out. first, that Hakim sounded both angry and anxious -- angry that FDA had not told him about their concern at the November meeting, and anxious to get off the call, get to work, and get this resolved
second, that Elite has never been more assured of success than now. why? because while this is a temporary setback for SequestOx, going through this process has confirmed that FDA has no problem with Elite's two-bead pharmacological approach (had SequestOx been an extended release rather than immediate release it would have been approved), and Elite is in its best financial shape ever -- easily good enough to be submitting another NDA each quarter through the end of 2017, especially since revenues are growing at a triple digit pace such that Elite actually turned a profit last quarter even after fully funding R&D
prior to 2008 the FDA would have issued an "Approvable" letter for SequestOx and explained in the letter what needed to be done to get approval