pdufa dates are relative targets that are oft not met for a variety of reasons, but drugs like SequestOx -- gone through 505(b)2 process, been granted priority review, and had successful phase III -- have an amazing 96% certainty of approval
with generic revenues growing so fast, that outcome might become the norm
if they would acquire or merge with Elite. they have a shared interest in controlled drug substances...
"The acquisition of Epic will provide a robust generic product portfolio which includes tablets, 2-piece capsules and powder dosage form products as well as a future product portfolio that will include a series of controlled drug substances."
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
explain how it dropped from $99 million at the end of March 2014 to just $12 million end of March 2016
and then stop saying Elite has a lot of debt and negatives on its balance sheet
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
there's nothing complicated about the share structure. just read the 10-k and ask whatever questions arise but, if you actually read it, i doubt you will have any problem understanding how many shares are outstanding and authorized
as for the number of shares -- unimportant! the only thing that matters is market cap and, on that score, Elite's cap is much, much lower than similar companies, and most of those companies have no revenues whatever let alone revenues that are paying for R&D
and the balance sheet is beautiful. nothing like when Hakim took over. it is now rock solid -- Elite is actually funding itself, including R&D, for the first time in its history. don't worry about the debt because it is almost entirely contained in the warrants and will disappear whenever they are exercised or bought back
finally, why are you still talking 1-2 million? have you read the latest report? do you not realize Elite had $5.2 million in revs the last quarter? that's for just one quarter, monkey, not a year, just one quarter. and we you start applying triple digit growth to that kind of number and then start factoring in some SequestOx sales in 2017, well...you got yourself quadruple digit revenue growth!
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
upon approval, SequestOx will become the only immediate release abuse resistant formula in the multi-billion oxy market
and 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 currently 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
he has also bought shares on the open market and put them in a trust fund
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
from the 10-k...
"Elite will receive a license fee computed as a percentage (50%) of net sales of the Products a defined in the Agreement and is entitled to multi million dollar minimum annual license fees. Elite will manufacture the product for sale by Epic on a cost plus basis"
what are you talking about? Elite has virtually NO debt. that entry on the balance sheet includes the value of warrants that have been issued. when the stock goes up, long term debt and stockholders' deficit also go up. and when the stock goes down, so does the debt and deficit
and if you don't want to accept that reality, then i will use your misinterpretation and ask you, isn't it terrific that Elite had $99 million in long term debt as of 3/31/14 and in just two years has paid in down to only $12 million?
i mean, wow, according to your shrewd reading of financial statements, Elite has paid off $87 million in debt in just two years! thanks, monkeybreath, for bringing that to our attention
why all this concern with one bead, two bead, 13 bead, or whatever? Elite has patents and a unique approach just as all the others, and there is room for all in the pain space
what is important is that pfizer and the others are fighting in the extended release space, while SequestOx would be the first abuse deterrent oxy in the immediate release space
the IR space is a multi-billion market in and of itself and it would seem doctors would be hard pressed to prescribe any IR oxy other than SequestOx once it is available
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
just no reason
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
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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.
earnings report in two weeks will show revenues growing at triple digit pace year over year, and there are many more and bigger generics awaiting transfer of site approval
but much, much, more important is the coming approval of SequestOx which is of major significance in and of itself but even greater is that the approval will essentially validate and set the stage for approval of Elite's entire abuse resistant line of drugs
Elite could wwell be the best stock anywhere to be holding now
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