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Perhaps you haven't noticed the wall getting tapped but not moving. Lots of shares bought @ 2.55 yesterday and cashing out?
Nice to see the bid creep up from the few brave souls who don't seem to mind these large market swings.
"Their markets have already gone generic"
And because of that we won't have the control games we've seen with Focalin, choo choo is right, lol
Trying to see if there's an update out there so we can understand the delay better on the lack of available lower strength generic Focalin XR tablets to the general public.
One bright spot is Teva launched the 40mg along with the 15 and 30 when our exclusivity expired on May 28th. That would mean on Nov 28th or shorly thereafter we should have that strength added for sales upon approval versus pre-approval.
Of a more interesting note, there didn't appear to be any updates on lawsuit activity between Novartis and Teva other than their settlement many years ago and we're held up because of Teva whose hands appear to be tied by Novartis. See the comments in the link as it gives good incites of the problem of shortages that's been going on for a least 5 yrs and the gaming that appears to be allowed. The good news, after 12-15-15 is Novartis' patent expires which should allow generic supply to meet market demand. I posted one comment in particular with the link.
I also think the Odidi's extended the convertible to only July because I believe no matter what the ANDA's do, Rexista will be parnered by then, we'll see.
phenyl 05-04-09 10:39 PM
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Re: Shortage of generic 10 mg d-MPH Teva tablets?
Quote:
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Originally Posted by atxlady73 (Post 737877)
Hello,
I have actually been scavanging for the last 4 months for the generic dexmethylphenidate 10 mg pills.
I asked my pharmacist to research why they were on backorder for so long.
When they called to inquire, they were told that the Manufacturer of the non-generic (Novartis) only allows a certain amount of generic pills to be created per quarter. At the time I inquired, two months ago, this was the answer. Now when I ask, they tell me they are on an indefinite back order and they're not sure when they will be able to produce pills anymore. I'm about to call my doctor tomorrow to get the Novartis Focalin because she's now on methylphenidate and has had a bad case of diarrhea and tonight she vomitted all over the bathroom and hasn't had anything to eat today shy of maybe 2 cups of "picking" at food all day. It also doesn't seem to be working for her behavior. She's been acting up quite a bit and has destroyed several things. She doesn't realize what she is doing and at times will be so uncontrollable that she hurts not others but herself. I'm going crazy not having her on Focalin - it does SO much better. I don't care if I have to pay $45 a month for the pills...it's her well being that matters.
I hope this has helped and I do feel your pain. I'm not a fan of Ritalin - even though I've been told Focalin is pretty much the same type of long term damage...
Good luck!
Heather
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Ah, so THAT'S why. The teva generic is an "authorized generic", not a TRUE off-patent generic. NOW I understand the problem more. With "authorized generics", the patent holder (Novartis in the case of Focalin) absolutely can limit the number of doses the generic drug maker can produce per quarter. I did not realize that this was an "authorized generic".
I'm just gonna tough it out and pay up for the brand name focalin IR 10 mg from Novartis (I take 10 mg 2x per day for 20 mg total, so I get 60 10 mg pills of IR dexmethylphenidate per month, which ends up costing like 40 to 50 bucks depending on the pharmacy -- although I think it's 50 always for me b/c I think the copay for brand Focalin is fixed with my insurance; for the generic Teva the copay is fixed at 10 bucks for the 60 pills). Focalin is the right med for my ADHD and I won't stop taking it because I need to pay a little more for a few months. It's STILL cheaper than Focalin XR which would be a 70 dollar copay for 30 20 mg XR capsules on my plan -- I certainly don't mind having to dose twice a day to save money -- the XR focalin isn't even a super advanced XR system that keeps blood levels really smooth, it just gives you half the dose immediately and half four hours later when the inert coating on the second half of the dose is eroded away ... so taking 10 mg IR d-MPH twice a day is the same damn thing.
Thanks for filling me in on what's going on with Focalin IR. I didn't know it was an "authorized generic". That makes a lot of sense in retrospect, because if Focalin IR was TRULY generic now, more than one company would be making generic versions. The fact that only Teva makes a generic instant release dexmethylphenidate is a glaring sign that it's an "authorized generic" and that the drug is not yet "fully generically available".
I'm sure lookin forward to when dexmethylphenidate IS completely generic though so I don't have to deal with this dose limit problem anymore.
http://www.addforums.com/forums/printthread.php?t=67741
Increase of 3M shares in the last yr is quite frugal I think most can agree. The ANDA delays with the limitations of Focalin strengths they can sell has really tied up the flexability that they had previously envisioned when they went after all this "low hanging fruit" initially so they would have the funds readily available when Rexista clinical trials begin.
Let's hope they can latch on to some grant $ with this dire need recognized by the medical community to help with the financing of phase 1. Once they get through phase 1, the data can be presented for parnership consideration, imo.
Hopefully we'll hear the positive details from their SPA meeting which could potentially shorten their approach.
Well, glad they beat the consensus. Was hoping to be at break even but a little more R/D and a little less revs. then I expected. Was encouraged by the summertime comment affecting less Focalin sales to school age children. That should pick up some now.
Yeah crazy Doog, S&P down app. 8% during that same period so approaching technical correction point. Just thought I'd point out the "line in the sand" stance of support taken on IPCI's bid at the moment.
Despite the major sell-off again today, 10 mm's are presently forming a wall @ 2.57, fwiw.
Based on IR the CFO stepping down was his decesion. Also a lot of companies just state a person resigns, resigns to persue other opportunities but IPCI gave a specific reason.
Not going to argue the poiint one way or the other just putting your comments in a different light with the info we have not just speculation.
Nice article. Thanks for posting the whole thing. Not sure what the CFO comment was all about. If he was a drag on the company or was replaced by someone else that was handy that would be different which wasn't the case. Might make sense that he saw a partnership forcing his hand eventually so grasp the opportunity presently? If so, his replacement would come in with the understanding of perhaps a 2 yr. or some limited timeframe?, imo.
Thought the same thing Z. Extra sauce please coupled with a higher share price as an apetizer may be the ticket me thinks.
Since it doesn't take much volume to move it either way I'm thinking it was driven down some to pick up a few more. Those who have scrutinized last qtrs. negative earnings report understands the reason and the continual prudent use of funds to keep expenses low like they've done many times before,imo.
A little plug for IPCI today.
Intellipharmaceuticals International, Inc. NASDAQ: IPCI) FULL REPORT
The company announced an enhancement of its Rexista(TM) abuse-deterrence technologies with a significant improvement designed to prevent overdose when more pills than prescribed are swallowed intact. Intellipharmaceutics’ new platform technology is branded PODRAS(TM) (Paradoxical OverDose Resistance Activating System). The PODRAS(TM) platform technology is covered by patents pending with the U.S. Patent and Trademark office.
Intellipharmaceutics’ most advanced application of the PODRAS(TM) platform to date is to its Rexista(TM) product candidate (oxycodone hydrochloride extended-release tablet), which is designed to deter abuse by both physical interference and overdose. Rexista(TM) oxycodone is an investigational drug, with a unique long-acting oral formulation of oxycodone intended to treat moderate-to-severe pain when a continuous, around the clock opioid analgesic is needed for an extended period of time. Rexista(TM) oxycodone is designed to discourage common methods of tampering associated with misuse and abuse of such prescription opioid analgesic. Based on this technology platform, Intellipharmaceutics has developed several drug delivery systems and a pipeline of products (our dexmethylphenidate hydrochloride extended-release capsules for the 15 and 30 mg strengths) and product candidates in various stages of development, including Abbreviated New Drug Applications (“ANDAs”) filed with the FDA in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.
Intellipharmaceutics also has New Drug Application 505(b) (2) product candidates in its development pipeline. These include Rexista(TM) oxycodone, an abuse-deterrent oxycodone, based on its proprietary nPODDDS(TM) novel Point Of Divergence Drug Delivery System, and PODRAS(TM) Paradoxical Overdose Resistance Activating System, and Regabatin(TM) XR pregabalin extended-release capsules.
BTW, what really sucks for us, as we are all aware, is the hatchet job we were handed, after getting approval of Focalin to market, to garner more market share with the other strengths.
It doesn't look like this is being resolved soon. We may even have to go another 14 months until the patent expires with Celgene before there will be movement with TEVA's launch. That maybe what they're doing, buying time as they have a broad revenue stream. I don't know, just speculating.
That's why I can't wait for the next ANDA to get more concrete revs coming in.
Thanks for relaying the info.
I believe when Shameze was an analyst he covered medical device companies which led him to his established relationship with IDC. His broad knowledge and expertise earned him a position on the board. He had to travel 2k miles one way to attend meetings with the company execs so "passionate" would be the right word, imo.
"Rexista - Kirin said we should be getting an update/news by the end of the year. He said this information was in one of the recent PR's from the company. I don't remember seeing that at all. Has anyone read that? Either way, if true, that is exciting."
I think this is what he may be referring to:
"Intellipharmaceutics currently expects to begin a series of clinical trials in Canada and the United States in the coming months to further evaluate Rexista™ incorporating its PODRAS™ platform."
http://www.intellipharmaceutics.com/releasedetail.cfm?ReleaseID=868259
I realize you have a shorter time frame so you won't appreciate my answer but.......
I'm shooting for that void above the 200mda @ 3.56 where the prices on the right of the chart change from .25 increments to dollars
Another great start out of the shoot today.
"I feel this is a simple case of an accomplished CFO moving up the career ladder."
Ok you shouldn't substitute my indepth analysis with a clear simplistic sentence, lol.
I agree though.
Ok, I put my good eye on the price for 15 mins after the close. Still 3.04, lol.
Third qtr earnings came out on the 1st of Oct. last yr so anytime between now and the 10th before Shameze packs up would be my guess.
Speaking of which I think he's got an executive position locked up with IDC as I research his involvement with the company in his capacity as director a couple of yrs ago. The present CEO was a director with Shameze,(who also was Chairman for a short period) and asked to step down by then CEO Lee to put his cronies in place. I think that relationship has brought him back to a management position with IDC, we'll see. Looks like it's a good time to get on board as growth is taking off. Their CFO was recently replaced.
I think it's too early to come to the conclusion that a partnership of any sort had forced his deceision to leave IPCI. So if I believe that then leaving a job paying roughly $333K in salary and compensation would have to be something of interest to him with a comparable compensation package even if it's more in stock then salary,imo.
"Dr. Sidong Huang, President and CEO of the Company stated: "I would like to express my appreciation to the management team and Board of Directors of IDC as well as all Company employees who have worked hard to generate increased sales activity and for the improved operating results for the last two quarters. The Company's sales and marketing efforts have been successful in increasing sales from IDC's existing customers. In addition, the Company is developing relationships with potential distribution partners. The Company is also in the process of developing of new product lines that it hopes to be registered and introduced into the marketplace later in 2014. IDC's plans for the dental segment are progressing and is expected to add to the Company's revenues in the coming periods."
http://www.imagingdynamics.com/index.php?option=com_content&task=view&id=414&Itemid=30&open=414
Lol, nice analogy oregon. You run it up just enough, sit back and wait for the next group to come to ya.
Up .14 on 19k, eom
Up .10 on 10k, eom
Yeah, not sure what the deal is. Thought it may have been an after hour trade but my TDA account shows 132k shares traded for the day but other feeds not picking it up. That would be a late 7-8k share sell??????????
Edit: Yahoo shows it as well??????????
Nice recovery. Down only .04, I'll take it on days like this! Accumulation continues.
"You're betting earnings will be bad based on what LearnToTrade?"
Doog asked you a very fair question LTT. I hope you can give him/the board a reasonable reponse.
To add to what he has already posted. Why were the earnings negative last quarter?
As it was explained, the Doc had his performance option pushed out another (2) yrs that would have expired last month, however, it had to be booked against last qtrs earnings which threw them negative for the qtr.
Secondly, after our exclusivity expired May 28th? on Focalin 15mg what did Shameze say our market was for the month of June for just our (2) strengths? As stated, 43% for the 15 mg, even after exclusivity, and 25% for the 30 mg. Now using that as a bench mark I would think the next (2) months in the qtr might be a little similar.
Thirdly, (now pay attention for this one) Shameze mention that ONLY 3/4 of the revs for the yr were BOOKED at the end of July totaling $7.7M. So maybe you can do the math and figure what 100% is with the difference yet to be reported through July only.
So what's your data to suggest another negative hit?
As far as the 2.75-2.80 gap filling I thought that might be a probability with 50dma below these numbers at the time helped along by large market sell-offs like today. With the 50dma @ 2.82 and stock hitting 2.90 it is apparent we're close enough to a support level to garner a floor. We'll see, I don't make predictions just try and gauge where we might go barring news. I think the anticipation of positive earnings coming out in 7-12 business days will keep this above the 50. Good luck with that small 2.45 gap.
BTW, there was a gap filled when the stock hit 3.80 before it retreated. You left .70 on the table when you sold @ 3.10. Now I understand you need 2.45 to get that money back. I don't put down people for making a profit regardless for what they could of had but timing the turnaround is just as difficult when the market is unpredictable.
Well, nice time for Shameze to slip on out. The whole market has a problem with it, lol.
If there's a price drop at the open due to Shameze's resignation I'm sure it will be short lived. He's been at it 4 yrs so I'm sure he's ready to move on.
Dr Amina has done the job for yrs. prior to Graham Neil who only lasted <1 yr. Since the pr mentioned she held that position once before perhaps there won't be much of a reaction.
BTW, when Neil resigned, they hired Shameze within a week or 2.
Hopefully Shameze has done all the leg work with our potential Rexista partner and all the newby will have to do is get up to speed on everything.
Edit: When I saw we had a pr I just knew we had an ANDA approval. Oh well, back to waiting.
Well, in lieu of the broad market sell-off, it's nice to see the end of day accumulation once the dumping started. Nice close for that reason.
Heating up here. Bid getting stronger, 10k Went off @ 3.10.
Sheesh, the stock is performing quite well in lieu of the broad sell-off today.
That's what I mentioned yesterday but didn't know the technical term for the line, lol.
Must be nice to have the US markets close @ bedtime (10:00)
Hey every little bit helps. That's 15% of today's volume so far, not too shabby
I wouldn't think it would cost a lot to launch a generic drug but they still have an agreement in place to utilize Par for future generic launch's if they so chose, in case I'm wrong.
I'd prefer they keep all the profits in house if they can go it alone. Perhaps that's why we haven't heard anything yet or that's what I'm hoping for anyway.
The stock looks like it is settling in on that mid bollie line. Perhaps it will ride it back up barring a major sell-off to fill that 2.80 gap, imo.
Mopar, with all due respect, do you think you might be asking that the cart goes before the horse?
Who is going to fork over the kind of money a licensing deal would bring in on a perceived technology not validated by any clinical trials and non-approval by the FDA (here in the US) that the end point meets the criteria agreed upon to deter drug abuse of any kind with any drug?
To be clear, when the company develop the PODDD's tech. platform it dealt with the abuse of the drug by the braking down and altering the characteristics of the tablet for more blatant abuse. PODRA's deals with the intact tablet making sure the abuse doesn't come from overdose by an over-prescribed supply. Now we are set to prove all of this out through clinical trials.
In the last pr, the answer is in the details. Look at all the speculative wording the company used (highlighted in bold by me) on something they feel confident about to submit a patent for but hasn't been clinically proven yet.
We should hear from the company on the start of these clinical trials after the plan they agree to with the FDA with the end points they wish to achieve with a partnership in place.
The PODRAS™ platform technology is covered by patents pending with the U.S. Patent and Trademark office.
"We believe this significant advance in our abuse deterrence technology has the potential to positively differentiate Rexista™ from other abuse-deterrent technologies of which we are aware, and represents an important step toward helping patients manage their pain safely," said Dr. Isa Odidi, Chief Executive Officer of Intellipharmaceutics. "In addition to its use with oxycodone, the new technology is potentially applicable to a wide range of drug products that are intentionally or inadvertently abused and cause harm by overdose to those who ingest them."
Intellipharmaceutics' most advanced application of the PODRAS™ platform to date is to its Rexista™ product candidate (oxycodone hydrochloride extended-release tablet), which is designed to deter abuse by both physical interference and overdose.
Preclinical studies of Rexista™ suggest that, unlike other third-party abuse-deterrent oxycodone products, if more tablets than prescribed are deliberately or inadvertently swallowed, the amount of drug active released over 24 hours may be substantially less than expected, even possibly approaching zero. However, if the prescribed number of pills is swallowed, the drug release should be as expected.
In January 2013, the United States Food and Drug Administration ("FDA") published a paper titled, Guidance for Industry: Abuse-Deterrent Opioids — Evaluation and Labeling, which cited the need for more efficacious abuse deterrence-technology.
In this draft Guidance, the FDA stated, "Opioid analgesics are often manipulated for purposes of abuse. Most abuse-deterrent technologies developed to date are designed to make product manipulation more difficult or to make abuse of the manipulated product less attractive or rewarding. However, these technologies have not yet proven successful at deterring the most common form of abuse - swallowing a number of intact pills or tablets to achieve a feeling of euphoria."
Dr. Ed Sellers, an internationally recognized clinical pharmacologist and Professor Emeritus, University of Toronto, and President of DL Global Partners commented "The risk of overdose due to taking more opiate analgesic than prescribed is a real one. The lack of delivery technologies to reduce that risk is an unmet public health need. The announced technology is promising. Confirmation of its clinical importance in human clinical studies would be a significant contribution to deterring abuse."
Intellipharmaceutics currently expects to begin a series of clinical trials in Canada and the United States in the coming months to further evaluate Rexista™ incorporating its PODRAS™ platform.
There can be no assurance as to whether or when the FDA will approve any Intellipharmaceutics' Rexista™ oxycodone application.
http://www.intellipharmaceutics.com/releasedetail.cfm?ReleaseID=868259
Wonder if the Doc has this covered already. What's another receptor in the tablet if you already have others unless it's chemically incompatible.
"Opioids are a class of drugs that are used to treat and manage pain. A common side effect associated with the use of these drugs are that they reduce the gastrointestinal tract’s motility, making bowel movements difficult and causing patients to strain, have hard or lumpy stools or experience a sensation of incomplete evacuation. Movantik belongs to a class of drugs called peripherally acting opioid receptor antagonists, which are used to decrease the constipating effects of opioids."
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm414620.htm
Love to keep seeing this meticulous accumulation!