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BondsSF, thanks for a thoughtful response.
The bioequivalence required only has to do with Oxycontin so the PODRAS has NOTHING to be bioequivalent to.
I contacted the company asking them if a Phase 3 will be needed with the PODRAS added and will let you know what they respond.
IPCI is not being up front about this
Show us anywhere with a factual IPCI quote, document, press release or filing what you're claiming>>>
IPCI playing 3 Card Monte with Rexista PR's
It's so easy to see if you read carefully. Everyone should go back and read every PR about Rexista. If it doesn't mention PODRAS then it is talking about the old formulation without PODRAS. The old formulation is a simple mechanical barrier ADF. Maybe they would let that slide by without Phase 3, but I doubt it. Now add PODRAS and you've added a completely novel mechanism of biochemical activation and/or deactivation. Companies have been trying and failing to develop this kind of technology for many years. The idea that an unproven, novel mechanism like this is going to be allowed to skip Phase 3 is farcical. The reason IPCI is not being up front about this is because Rexista with PODRAS is 2-3 years and $25-50 million away, even with Fast Track. If it gets approval, it will be one-of-a-kind best-in-class blockbuster of epic proportions just the way everyone thinks. But it is not six months away, and the company will need to raise $$ to get it done.
Mark this post. 2-3 years. $25-50 million.
N2KA, Rexista with PODRAS will require Phase 3
All published bio-equivalence data (and FDA comments about not needing Phase 3) thus far has been for the old formulation WITHOUT PODRAS. That was simply a mechanical-barrier ADF. There is no substantiated bio-equivalence as of yet for Rexista with PODRAS, nor has the FDA ever said that Rexista with PODRAS will not require Phase 3. Addition of PODRAS makes all prior studies moot. I guarantee there will be a Phase 3 requirement, assuming it even passes Phase 1 bio-equivalence, which as of yet, it has not. You need to think of the addition of PODRAS, which is what qualifies for Fast Track, as an entirely new drug which needs to start over from the beginning. I'd give you my opinion on the likelihood of successful Phase 1 for Rexista with PODRAS, but there has been no disclosure or description of PODRAS mechanism, making it impossible.
Hi JJ. Who can predict the FDA?
I've touched on this before, whereas I compared the FDA to a bouncer at a college bar and ADF is your I.D. to get in. Fake ID's are fine, but you must show something to get in. I also assert that the FDA will not hand over a monopoly to a single company, and so there will need to be multiple viable ADF's before non-ADF's will be pulled.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=113499564
I do not think ELI-200 is going to be the test case, since there is no other true ADF OxyIR. Oxaydo (nee Oxecta) has "abuse-deterrent properties" but did poorly in HAL studies and was never given ADF labeling. Along with Oxecta's 20X price premium over generic, it was never a true or viable ADF.
I think the better test case is going to be Zohydro. When approved in 2014, it had no abuse deterrent properties, and FDA took a lot of flack from every direction. Their reasoning never made sense:
http://www.fiercepharma.com/story/under-fire-fda-chief-hamburg-defends-approval-pain-pill-zohydro/2014-03-14
"We recognize that this is a powerful drug, but we also believe that if appropriately used, it serves an important and unique niche with respect to pain medication and it meets the standards for safety and efficacy," Hamburg said.
...
"It doesn't do any good to label something as abuse deterrent if it isn't actually abuse deterrent, and right now, unfortunately, the technology is poor," Hamburg said.
In the midst of all the controversy, Purdue Pharma--the company that originally developed and sold the highly abused pain pill OxyContin--said it has finished a Phase III trial of its extended-release formulation of hydrocodone bitartrate, and that indeed it is abuse-deterrent.
Taking cut, broken, chewed, crushed, or dissolved ZOHYDRO ER enhances drug release and increases the risk of overdose and death. With intravenous abuse, the inactive ingredients in ZOHYDRO ER can result in death, local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury.
There is a legal issue here where if one has access to an ADF opioid and chooses not to prescribe it going with the non-ADF
instead one runs the risk of liability should something happen to the patient by abusing the non-ADF he/she prescribed.
Mazeppa, SEC complaint was Dianne's idea.
My intention in talking to her was to get her to discuss the issue with NH and Legal and then get back to me. When I say she asked me 10+ times if I was a securities lawyer, I'm not exaggerating. She would say something to the effect of "I don't get what you think the problem is." And when I would try to explain my concern, she kept responding with the securities lawyer question. It was actually very childish. I said multiple times, "Tell me how long you need to get with them and I'll wait to hear from you." And all she would say is, "Are you a securities lawyer?" My plan was to do what you said and go over her head to e-mail Nasrat (his address is not that hard to figure out, Chris Dick's also). It was Dianne who repeatedly refused to even look into the question and told me 3X to file a complaint with SEC. And you may notice that I did this 2 months ago and just now mentioned it. It is very annoying that every time a contrary opinion gets expressed on this board the same posters pop up with "Best call I.R." or "You need to call Dianne." Please. And BTW, Dianne knows my real name, e-mail, phone, and share count.
For the record, I am not against the Epic ELI-200 deal. I think it makes strategic sense in multiple ways. I understand completely why the exact details are not being made public. But the agreement is exactly this: a secret deal with a private company with whom the CEO has a secret fiduciary interest. And that I do have a problem with. While there is a good reason to keep the details of the ELI-200 deal secret, what is the reason to keep secret the details of Nasrat's membership in Epic? Further, I haven't even criticized the Novel deal, other than to point out that it is a perfect example of how shareholders can be adversely effected by secret dealings with private companies who have closed books.
Also, too, I love your posts and look forward to many more. I'm here to stay.
DrugDoctor, What Is Your Opinion?
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=114766207
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=115371978
What is your opinion on these 2 recent examples of e-mails from Dianne Will in which she clearly misinforms shareholders. I do not think these are examples of malfeasance but rather they demonstrate her incompetence. In the first, she reveals her misunderstanding of the difference between Priority Review and Fast Track. She tries to equate ELI-200's Priority Review and IPCI Rexista's Fast Track. In the second, she demonstrates her misunderstanding of the entire FDA review process.
Regardless of her terrible demeanor, which many on this board have attested to, what is your opinion on her repeated demonstrations of incompetence and lack of professional curiosity? I doubt any single person reading this has the kind of employment where they could repeatedly give incorrect and demonstrably false information to their main constituency without getting fired. In my practice, I am constantly looking things up to make sure I'm using evidence-based strategies and utilizing the most up-to-date data in my clinical decisions. Do you think it's okay for Dianne to be so thoroughly incorrect on matters which she could easily obtain a better understanding if she only tried?
Dianne Will urged me to file SEC Complaint
The last time I spoke with her regarding Nasrat Hakim’s membership in Epic she was her usual dismissive, condescending nature. She asked me 10+ times if I was a securities lawyer. She refused to consider addressing the issue with NH or the legal team, and she said not once, not twice, but three times that if I wanted an answer to the question then I should file a complaint with the SEC. So I did. Maybe others should, too.
Help" <help@sec.gov>
To
XXXXXX@XXX.com
May 20
Dear Mr. XXXXXXXXX:
Thank you for contacting the U.S. Securities and Exchange Commission (SEC). We appreciate your informing us of your concerns regarding Nasrat Hakim and Elite Pharmaceuticals.
The Office of Investor Education and Advocacy (OIEA) processes many complaints received from individual investors and others. We keep records of the correspondence we receive in a searchable database that SEC staff may make use of in inspections, examinations, and investigations. In addition, some correspondence received by OIEA is referred directly to other SEC offices and divisions for their review. If they have any questions or wish to respond directly to your comments, they will contact you.
The SEC conducts its investigations on a confidential and nonpublic basis and neither confirms nor denies the existence of an investigation unless the SEC brings charges against someone involved. We do this to protect the integrity and effectiveness of our investigative process and to preserve the privacy of the individuals and entities involved. As a result, we will be unable to confirm whether an investigation exists or provide you with any updates on the status of your complaint or of any pending SEC investigation. Information on our policy is enclosed. You may wish to check our website, www.sec.gov, for information about pending SEC civil actions, administrative cases, and other matters.
If you have any questions, please contact me.
Sincerely,
Rinell Randolph
Attorney
File Attachment:
Correspondent Name: Mr. XXXXXXXXXXXX
Create Date: 2015-05-17 19:20:24
Origin: Web
File #: HO::~00495440~::HO
Description:
Nasrat Hakim became CEO of Elite Pharmaceuticals in August 2013. In November 2014, he began receiving disbursements of shares of ELTP stock from Epic Investments, which is an arm of Epic Pharmaceuticals, a strategic partner of Elite. He has received disbursements of ELTP stock from Epic on multiple occasions, including disbursements to his IRA and to a separate entity he controls, Mikah Pharmaceuticals. There has never been any public disclosure of Nasrat Hakim's relationship with Epic Investments. I have queried Investor Relations and was only told that Nasrat Hakim was a member of Epic Investments prior to becoming CEO of Elite. If this is true, then this should have been disclosed at the time. Likewise, he did not disclose any indirect ownership of Elite through Epic Investments on his initial SEC filings. And if he was always a member of Epic Investments, then why did he not receive any disbursements until Novemeber 2014? I believe that he became a member of Epic Investments sometime after he became CEO of Elite and before November 2014. I believe that no matter what his relationship with Epic and when it started, the details of the relationship should be publicly disclosed. Epic and Elite are very closely related. Members of Epic hold substantial shares in Elite, and Epic's CEO and Executive VP are both Elite Directors. Epic executive Ram Potti is a former Elite Director. There is no way for Nasrat Hakim to be a member of Epic Investments without it being material information to Elite Shareholders. Either he failed to disclose the relationship when he became Elite CEO or he failed to disclose it when he became a member of Epic while CEO of Elite. Either way, he needs to disclose to the exact nature of his relationship with Epic to Elite shareholders.
Novel = Privately-Held Corporation = Epic
I have a hard time understanding how some can have a What’s Done Is Done attitude toward what appears to be $40+ million underpayment. That amount would cover the entire LPC I Deal. Yes, maybe there is not much to be done about it now, but how do we know the exact same thing is not happening again right now with Epic? I have previously discussed the Novel deal in the context of Nasrat Hakim’s cozy relationship with Epic and my concern about an Epic-Elite merger. The following post is from April, long before the Epic ELI-200 deal. Elite shareholders do not know any details of the ELI-200 deal, and likewise, the nature of Nasrat Hakim’s Epic membership still has not been publicly disclosed. And further, if NH was cooking up the ELI-200 deal with Epic, including Epic retroactively paying the development costs, why not make the same deal months ago with the development money up front and prevent much of the LPC dilution and the need to accept pennies on the dollar for Novel?
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=113217587
There was quite a bit of speculation prior to the announcement that the Novel payout would be in the range of tens of millions. But Novel being a private company with closed books, it was all speculation, and in the end, it was not even close. Shareholders never saw any details, and we have to trust that we were properly compensated for our stake. The final deal was probably hammered out by the two principles over a fancy dinner and a bottle of fine wine. I'm certain that many extrinsic factors were considered beyond valuation, including quick payout and avoidance of litigation. My suspicion is that we probably got less than we deserved (but not a lot less). My point is that our stake was worth what the big players privately decided it was worth and only somewhat based on "valuation".
Now let's say we enter into a merger with a similar privately held corporation. Epic's books are closed to ELTP shareholders, but ELTP's books are wide open. And not only that, but the Directors of each entity are so incestuous that whatever the big players privately decide will surely be approved by both BOD's. If we entered into some type of merger next week, Epic's valuation based on current revenues would dwarf ELTP's, and the merger would go down 9:1 with ELTP shareholders being diluted out 10 fold. But we all hold ELTP shares because we think revenues will increase by hundereds of multiples over the next 10 years. By 2025, the revenue asymmetry would be reversed, and it would be Epic shareholders enjoying the dividends of ADF revenues. Why would Nasrat Hakim go for any such deal? Well, I don't know what his deal is with Epic, does anybody?
And by the way, who says such a merged company would be a publicly-traded company? Why couldn't the two BOD's agree to merge and go private. Pay off ELTP shareholders at a premium price of 0.30? How disappointing would that be?
I'd rather be early to the party than late for dinner. And this party is about to start rocking. ELI-200 Phase 3 is wrapping up. FDA Priority Review. First ADF revenues in company history first half 2016.
ELTP 2 bead pharma-based ADF is the impenetrable fortress of the ADF Wars. It cannot be chewed, crushed, snorted, dissolved, or injected. Period.
http://www.marketwatch.com/story/elite-pharmaceuticals-releases-positive-top-line-human-abuse-liability-data-for-eli-200-an-opioid-abuse-deterrent-product-2014-09-09
The study results demonstrated statistically significant (p <.0001) lower measures of drug liking, drug high and good drug effects for Elite's manipulated (crushed) ELI-200 when compared to the manipulated (crushed) drug listed comparator product and found 91.9% of the subjects experienced increased drug liking with the comparator product compared to ELI-200 in non-dependent recreational drug users when administered intranasally.
FDA approval of what? Lunch menu?
Is Naltrexone An Ineffective Treatment for Alcoholism?
By Richard Juman 07/16/15
http://www.thefix.com/content/naltrexone-ineffective-treatment-alcoholism
The results call into question the overall efficacy of naltrexone for alcohol use disorder. But could the drug be significantly more effective if it were simply prescribed differently? Psychiatrist Stephen Cox argues that The Sinclair Method, in which naltrexone is only taken one hour prior to consuming alcohol, instead of the once-every-morning technique that is most commonly used, is significantly more effective than the traditional regimen.
Unfortunately, although The Sinclair Method is tremendously more effective and much less expensive than the traditional technique, it is still virtually unknown in the United States. Used the proper way, the treatment is an astoundingly effective approach to treating alcohol use disorder, with success rates of around 78%.
So far as the generic pills go, there is no giant pharmaceutical company bombarding us with TV commercials of pretty actor people talking about, "Ask your doctor if naltrexone is right for you."
Be sure to see this important update.
http://seekingalpha.com/article/3337525-more-negative-indicators-from-generex-biotechnology?auth_param=9bvcl:1aqpnff:8b2384a5c78c005e66636a887c044956&uprof=45
Apparently, things are not looking good for GNBT. In other news, the sky is blue and water is wet. Thanks, Nick.
Thanks for replying in such detail.
It is very helpful to see when your sales were made and what the share price was at the time. I think one of the things that seem so discombobulating is the sheer SIZE of the deal. I would be wearing rubber pants making $335,000 trades. You've got some heavy gazumbas, eh Angelo? Thanks for the lesson.
I don't get it from buyer's perspective.
If put option buyer is spending $250,300 (44700 x 5.60) for the option to sell 44,700 shares for $7.50 (335,250), then to receive even puny 5% ROI (250,300 + 12,515 = 262,815), the put option buyer is betting the share price will fall below $1.62 (335,250 - 262,815 = 72,435 / 44,700). Who would bet $250,300 that IPCI would fall below $1.62 in order to make $12, 515?? Doesn't add up.
umiak, is he missing a few decimal points?
It seems like he is saying he received $5.60 per share instead of $5.60 per option contract for 100 shares. He's saying he got $250,000 for 447 ICPI put options, which if true, I'd like to know who bought them. I'd want to talk to them about buying some of my shares of ELTP.
I hope he keeps more cash in his account than I keep in mine. Jeebus.
What kind of put option is this?
Well... no stock has been PUT to me yet from the 447 July 2015 $7.50 PUTS I sold... but I know that on Monday morning there will be 44,700 shares of IPCI in my account (they take out $335,250 of cash out).
I don't know how it works on the other end - let's assume it's one individual... does he have the stock and it gets pulled away from him??? does he automatically go short??? does he have to buy 44,700 shares??? I really have no idea what happens on the other end.
Anyway... my average sale was $5.60 - so it's like paying $1.90 for the stock. $3.71 - 1.90 = $1.81 x 44,700 = $80,907 profit (all paper profit of course) - nice little bundle... but peanuts compared to what I expect it to make me going forward.
ADF Wars: Zohydro with BeadTek™
http://www.pernixtx.com/news/pernix-launches-zohydro-er-with-beadtek/
About BeadTek™
BeadTek technology was developed using safe, well-known excipients and proprietary manufacturing processes to create an inactive ingredient that immediately forms a viscous gel when crushed and dissolved in liquids or solvents. All of the beads within the medication capsule are indistinguishable in color, shape, density and size, and do not impact the drug release profile when taken as directed.
ZOHYDRO ER must be taken whole [see Patient Counseling Information (17)]. Crushing, chewing, or dissolving the beads in ZOHYDRO ER capsules will result in uncontrolled delivery of hydrocodone and can lead to overdose or death [see Warnings and Precautions (5.1)].
Taking cut, broken, chewed, crushed, or dissolved ZOHYDRO ER enhances drug release and increases the risk of overdose and death. With intravenous abuse, the inactive ingredients in ZOHYDRO ER can result in death, local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury.
Tenor, don't forget about taxes.
All he has to do is get the pps to around 7 per share to become a billionaire.
The bill would give the FDA $110 million more annually over that period. Its budget has been over $4 billion.
I love it when he talks that way.
Nasrat Hakim:
...I’ve said this before, I have more than a dozen ideas of our stock that are ready to go into clinical trials and into the market. We don’t have to mind or to execute all of them, so when we decide which are the cream of the top, the top two, three or four and focus on these, keeping in mind how much they’re going to cost..
You do not sell a $1 billion technology for one product’s price.
It does not fit at all.
How does this fit in with this topic
The Company believes that upon successful completion of this Phase 3 study, CytoDyn will have the opportunity to seek accelerated approval for PRO 140 based on previously FDA granted fast-track candidate designation.
It is beyond moot, it is factually untrue.
It is a moot point. No pharmaceutical in their right mind would ever proceed in a key clinical trial prior to receiving a FDA approved protocol. Since the pharmaceutical is seeking USA Commercial approval for marketing the decision is very simple to wait for a FDA approved Protocol before proceeding with the trial.
Dianne Will, Wrong Again
Furthermore, here is ELTP IR Diane Will's response to my question regarding the FDA's approval of the Phase III protocol:
Quote:
The answer to your question is a company could not move forward with a Phase III clinical trial protocol without FDA approval.
It is the sponsor’s responsibility to outline the purpose of the meeting in the meeting request. The sponsor should provide adequate and relevant information in the briefing document to support the purpose of the meeting. After a meeting is requested and granted, CDER should remind sponsors that it is their responsibility to provide additional detail about the purpose of the meeting in the meeting briefing document. The sponsor generally asks whether specific studies or trials, clinical or nonclinical, will be sufficient in design and quality to support the drug development stage discussed at the meeting. There may be other purposes, such as discussion and planning for risk management of an identified safety concern.
reasonable argument for hysingla being inferior to Eli-200
The study results demonstrated statistically significant (p <.0001) lower measures of drug liking, drug high and good drug effects for Elite's manipulated (crushed) ELI-200 when compared to the manipulated (crushed) drug listed comparator product and found 91.9% of the subjects experienced increased drug liking with the comparator product compared to ELI-200 in non-dependent recreational drug users when administered intranasally.
Approximately 80% (n = 20) of subjects had some reduction in drug liking with tampered HYSINGLA ER relative to hydrocodone powder.
MT, multiple people have argued "bid support" manipulation at 20 cents, including myself. I would refer you to my post, but it was deleted.
NASDAQ, Purdue's ADF depends on the drug
http://www.purduepharma.com/news-media/2015/01/hysingla-er-hydrocodone-bitartrate-extended-release-tablets-cii-now-available/
Hysingla™ ER (hydrocodone bitartrate) Extended-Release Tablets CII Now Available
A Once-Daily Opioid Formulated with Abuse-Deterrent Properties
Stamford, Conn. – January 26, 2015 – Purdue Pharma today announced the U.S. commercial launch of Hysingla™ ER (hydrocodone bitartrate) extended-release tablets CII, a once-daily (every 24 hours), single-entity medication formulated using Purdue’s proprietary extended-release solid oral platform, RESISTEC™. Hysingla ER is the first and only hydrocodone product to be recognized by the U.S. Food & Drug Administration (FDA) as having abuse-deterrent properties that are expected to deter misuse and abuse via chewing, snorting and injection. However, abuse of Hysingla ER by the intravenous, intranasal, and oral routes is still possible.1
Our enemy is Reuters, not Egalet.
We want Egalet's morphine out there with ours. Viable ADF's = generic nonADF's pulled from market. We want to compete with Egalet, not generics.
ELTP needs more retail to slap the ask and not bid sit.
Egalet says drug less likely to be abused than other painkillers
(Reuters) - Egalet Corp said data showed its experimental painkiller was less likely to be abused than a form of morphine already being sold.
...
Some of the other companies that are developing abuse-deterrent painkillers are Pain Therapeutics Inc, Acura Pharmaceuticals Inc, Durect Corp, IntelliPharmaCeutics International Inc, KemPharm Inc .
So what makes ELTP a good investment?
As opioids become harder to abuse, heroin use (and heroin deaths) increases. Unfortunately, heroin is as pure and as cheap as it ever has been. Fortunately, that problem is not for Elite to solve.
John, evidence says you are 100% correct.
Knowing what I know if Elite is successful; the addicts; the biggest buyers of opioids; will stop buying them and move on. Elite is damned if it succeeds and damned if it doesn’t.
Despite a reduction in U.S. abuse of prescriptions, however, heroin overdose rates rose 23 percent over the same period, suggesting a number of pill addicts turned to street drugs.
Jeebus. I'm very sorry to hear that.
Pharmaman2015, oral abuse is the most common.
There is no currently-available or even publicly-describred ADF that prevents oral abuse by swallowing whole pills, although multiple companies are working on this, including ACUR and IPCI. Elite's 2 bead modular pharma-based ADF would prevent crushing/chewing then swallowing, which is nearly equivalent to snorting for time to max blood concentration and euphoria.
Collegium's recent HAL study of their DeterX proves that OxyContin's hard-shell ADF is entirely defeated by this method of abuse. You can read my summary and how it relates to Elite, assuming it has not been deleted by a Mod for the third time:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=114925235
Doctor shopping is getting harder.
In my state, recent law changes require me to have an active registration with the statewide automated opioid reporting system and to check it quarterly on any patient for whom I prescribe opioids.
https://pharmacy.ohio.gov/Documents/Pubs/Special/FAQs/Frequently%20Asked%20Questions%20-%20HB%20341%20-%20Mandatory%20OARRS%20Registration%20and%20Requests.pdf
Q5) As a prescriber, under what circumstances am I required to request, assess and document receipt of a patient’s OARRS prescription history report?
UPDATED
Beginning April 1, 2015, Ohio law establishes several new requirements for Ohio prescribers related to the Ohio Automated Rx Reporting System (OARRS):
? Before initially prescribing or personally furnishing an opioid analgesic or a benzodiazepine to a patient, the prescriber must request patient information from OARRS that covers at least the previous 12 months.
? The prescriber must also make periodic requests for patient information from OARRS if the course of treatment continues for more than 90 days. The requests must be made at intervals not exceeding ninety days, determined according to the date the initial request was made.
? Under the circumstances described above, the prescriber is required to assess the OARRS information and document in the patient record that a patient prescription history report was received and assessed.
Something Smells Like Dilution.
Yep, must be this...
http://www.prnewswire.com/news-releases/generex-announces-capital-investment-300104324.html
Generex Announces Capital Investment
WORCESTER, Mass. and TORONTO, June 24, 2015 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) today announced that it entered into a securities purchase agreement with an institutional investor on June 24, 2015. The investor has agreed to purchase in a private placement an aggregate of 500 shares of the Company's newly designated non-voting Series G 9% Convertible Preferred Stock ("convertible preferred stock") and warrants to purchase up to an aggregate of 100% of the shares of its common stock issuable upon conversion of the convertible preferred stock ("warrants") at the closing. The convertible preferred stock and warrants will be sold in units, with each unit consisting of one share of convertible preferred stock and a warrant to purchase 100% of the shares of the Company's common stock issuable upon conversion of such shares of convertible preferred stock. Each unit will be sold at a negotiated price of $1,000 for an aggregate purchase price of $500,000. An aggregate of 66,666,666 shares of the Company's common stock will be issuable upon conversion of, or exercise of, the convertible preferred stock and warrants issued at the closing. In addition, until the one year anniversary of the date upon which the Company's stockholders approve an increase in the Company's authorized capital, the investor may, in its sole determination, elect to purchase, in one or more purchases, additional units consisting of convertible preferred stock and warrants at a purchase price of $1,000 per unit with an aggregate subscription amount thereof of up to $500,000, which units will be identical to the units of convertible preferred stock and warrants issued in connection with the initial closing.
The convertible preferred stock has an effective conversion price of $0.015 per share, subject to adjustment under certain circumstances. The convertible preferred stock will accrue a 9% dividend until June 24, 2018 and, beginning on June 24, 2018, and on each one year anniversary thereafter, such dividend rate will increase by an additional 3%. The dividend will be payable quarterly in cash, or at the Company's option, in shares of common stock. In the event that the convertible preferred stock is converted prior to June 24, 2018, the Company will pay the holder of the converted preferred stock an amount equal to $270 per $1,000 of stated value of the convertible preferred stock, less the amount of all prior quarterly dividends paid on such converted preferred stock before the relevant conversion date. Such "make-whole payment" may be made in cash or, at the Company's option subject to the satisfaction of certain conditions, in shares of its common stock.
Subject to certain ownership limitations, the warrants will be exercisable at any time after their date of issuance and on or before the five year anniversary thereafter at an exercise price of $0.015 per share of common stock, subject to adjustment under certain circumstances. The exercise price and number of shares of common stock issuable upon exercise will also be adjusted on a full ratchet basis if the Company sells or grants any shares of common stock or securities convertible into, or rights to acquire, common stock at an effective price per share that is lower than the then exercise price, except in the event of certain exempt issuances.
A tough (but typical) week for small-cap biotech.
The Grind. MM's will slowly grind this down day by day until there are revenues to support the price. Always remember that price is different from value, but the two always find equilibrium eventually. Use low-price opportunitues to continue to accumulate your core position of high-value stock. Good news will give spikes, so set aside some for trading on the spikes in order to accumulate a bigger core. But until there are revenues, The Grind will continue and you'll have the chance to get them back. Always keep your core position in tact, though, because one day THE NEWS will hit, and you don't want to be on the sidelines. GLTA.
pte, collegium DeterX is a unique ADF
It is a physical-barrier ADF, but the capsules can be opened and the microspheres can be dispersed in pudding or apple sauce or put down a gastric tube. Obviously, this would not be possible with any of the other physical barrier ADFs. As far as I know, Elite's capsules can be opened up and the beads could also be put in food, as long they were not crushed. Not sure about a G-tube, as beads of a certain size would clog the tube.
This is a cool HAL study which would support Tier 1 ADF labeling. What they did is to compare the bioavailabilty after oral intake of crushed DeterX oxy vs. crushed OxyContin vs. crushed oxyIR.
http://finance.yahoo.com/news/collegium-announces-publication-comparing-effect-121500225.html
Crushing Xtampza ER demonstrated no increase in Cmax, Tmax, or AUC and was bioequivalent to taking Xtampza ER intact capsules.
Crushing reformulated OxyContin demonstrated an increase in Cmax and a decrease in Tmax, and was bioequivalent to crushed IR oxycodone tablets.
intelligent and educated physicians
Half of doctors unaware how opioids are abused
Researchers found in a survey that one-third of doctors did not know the most popular method of abusing opioids was swallowing whole pills. Almost half thought that abuse-deterrent versions of the pills that can't be crushed and snorted or injected were less addictive that the regular pills.
Egalet Announces Launch of Specialty Pharmaceutical Sales Force
http://www.prnewswire.com/news-releases/egalet-announces-launch-of-specialty-pharmaceutical-sales-force-300103180.html
The sales force will focus on the top prescribing healthcare providers who prescribe pain medication. Sales representatives will begin making office visits to educate healthcare providers on SPRIX, a non-steroidal anti-inflammatory drug (NSAID) indicated in adult patients for the short-term (up to five days) management of moderate to moderately severe pain that requires analgesia at the opioid level, following the completion of sales training. Promotion of OXAYDO, the first and only approved immediate-release oxycodone product formulated to discourage abuse via snorting, will begin by the end of the third quarter.