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."
just no reason
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
The danger is primarily with extended release formulations that contain a larger amount of oxy. a user who snorts or injects an abuse resistant extended release will be frustrated because the naltrexone will block the high and they might resort to using additional capsules, the naltrexone will keep blocking the high no matter how many they take but their body will still react to the overdose and they could experience a seizure during withdrawal -- but that would be due to oxy exposure, not naltrexone exposure
of course, the same could happen with an immediate release formulation but the user would have to take a whole lot more capsules because they contain a lot less oxy, and it is expensive and hard to get that many capsules -- which is why addicts will simply seek heroin
the FDA is definitely concerned about overdoses of all kinds (the increased availability of narcan is evidence of that) and they don't want folks switching to heroin but we have an oxy epidemic that has to be addressed, and the FDA is doing what it can within its authority
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"
with generic revenues growing so fast, that outcome might become the norm
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
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!
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
nobody, but nobody, has Elite's two-bead technology, not pfizer, not teva, not anybody
Elite ALSO has one-bead technology that is essentially the same as what pfizer is doing and, though Hakim is disappointed they got there first he also appreciates that it would have cost an arm and a leg to go first and Elite can now benefit by what pfizer went through and get Elite's version through FDA cheaper and quicker -- though it obviously will not be worth as much
but do NOT confuse immediate release SequestOx with all the extended release entries out there. SequestOx will be the first abuse resistant immediate release oxy, the first in the largest segment by far of the oxy market, and it will have established itself well before any competition shows up, yes, there are giants playing in the field of abuse resistance but when it comes to immediate release they are still in the parking lot while Elite is closing out the ninth inning with a 10 run lead
seems FDA offered a label but company said abuse resistant or nothing, and they got nothing
there were only about 27 million shares left to sell Lincoln out of the original 108 million shares under the agreement of July 2014. the S-1 clearly states that the "63 million shares" of this prospectus represents the remaining 27 million plus the 36 million or being added to the agreement…
“Although the Purchase Agreement provides that we may sell up to $40,000,000 of our common stock to Lincoln Park, only 63,000,000 shares of our common stock are being offered under this prospectus, which represents (i) 872,388 shares registered, remaining unissued under the Prior Registration Statement which are issuable to Lincoln Park as a commitment fee, (ii) 26,258,385 shares registered and remaining unsold under the Prior Registration Statement and issued or issuable to Lincoln Park under the Purchase Agreement and (iii) an additional 35,869,227 shares which may be issued to Lincoln Park in the future under the Purchase Agreement.“
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
already profitable except for R&D, and that R&D is going toward a slew of abuse resistant drugs that are collectively worth billions
what makes it especially great is that SequestOx is just the first of an abuse resistant line using the same technology. once FDA approves SequestOx it will be a green light for the rest of the pipeline
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
Manufacturing and Supply Agreement . ELITE shall supply Product to EPIC at cost plus ten percent (10%) and the parties agree to execute a separate Manufacturing and Supply Agreement (the “Manufacturing Agreement”)."
basically the same issue xtampza faced, e.g., when to take with respect to food
language was put into xtampza's label instructing that it be taken with food...
"• Instruct patients to take XTAMPZA ER capsules with food in order to ensure consistent plasma levels are achieved."
in the case of SequestOx, the label would instruct patients to sprinkle on food, or take before eating
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
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