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Looks like ELTP is breaking wide open!
Huge gains here!
Gonna move above $0.18 any week now!
Major buying pressure lately, on the verge of some huge catalysts, and rumors of buyouts!
It's a great day to say I own IPCI!
News any time now, new ANDAs any time now, deals any time now...
Going to be good
Long IPCI!
I tend to agree with you there Angelo. They had a timeline estimation, then adjusted it. With no new updates, I am starting to believe the buyout and partnership rumors.
Should be any day now when news breaks
Frugal, Love the response! Best laugh I've had all day!
Long IPCI,!
Very true...sell orders need to raise their price. That .67 is a hard one to break through. Too many people who bought in the 50's are taking their 15% profit. When you look at the people who bought in last summer at over a dollar...more than 100 million shares still being held. Once the flippers get out of the way, this will easily surpass $1.00. With positive data, and a good partnership, this could easily eclipse the $5-$10 mark.
Good Luck everyone!
Morning Doog, looking for more fireworks today! Maybe the buyout today will jump to $15...lol
Bring on the catalysts!
Long IPCI!
Right...certainly was red yesterday too...funny!
Good Luck!
Not a rumor...Odidi had said in a previous interview that he wouldn't sell a share for less than $12.00. I could dig it up, but really I'm not concerned. If you go back a couple hundred posts, you'll see the excerpt. He had also said he was building a $2BN company...so, $11.50 is laughable!
Best of luck!
Not even the tip of the ice burg....they turned down $12.00 per share a while back, and are now on the verge of several catalysts coming to fruition and a huge NDA submittal to the FDA. Realistically it will be in the neighborhood of $20-$40 if there is a proposal that would be taken seriously.
Good Luck!
Number one on the break out board, so there are going to be lots of eyes checking in on IPCI over the next 24-48 hours!
If nothing else, maybe we can get closer to that $6.50 price estimate that every researcher on the planet puts IPCI at!
Then the buy out rumors would be closer to the $20-40 estimate that we all believe would be more realistic.
Tomorrow is another day!
Long IPCI!
Its a shame that it is halted, this could have easily shot over $10 in the last hour. I can't wait to see where we open up at tomorrow! Going to be an interesting day!
Good Luck All!
Long IPCI!
C'mon Doog, you know it is because of the lucrative deal they just signed on the Generic Keppra! LOL
Thanks for all your DD on this one!
Top line results coming along with a lucrative partnership and follow on NDA submission to the FDA!
Bring on the Good News!
When might we expect an update for the Generic Keppra XR?
Does it contain "controlled-release delivery technologies" as well?
It has been since February since the approval, they have got to be close to striking a deal with someone by now?
http://www.intellipharmaceutics.com/releasedetail.cfm?ReleaseID=957022
February 24, 2016
Intellipharmaceutics Announces FDA Approval for 500 mg and 750 mg Generic Keppra XR®
TORONTO, Feb. 24, 2016 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs announced that the Company today received final approval from the U.S. Food and Drug Administration ("FDA") of the Company's abbreviated new drug application ("ANDA") for levetiracetam extended-release tablets for the 500 mg and 750 mg strengths. The Company's newly approved product is a generic equivalent for the corresponding strengths of the branded product Keppra XR® sold in the United States by UCB, Inc.
Dr. Isa Odidi, the CEO and a co-founder of Intellipharmaceutics, stated, "FDA approval of our application for a generic version of Keppra XR® is an important milestone for the Company. It is our first approved product developed in house at Intellipharmaceutics without the support or regulatory input of a development partner. We believe that this approval of our generic Keppra XR® product represents a strong validation of our core drug development and regulatory competence and our controlled-release delivery technologies. The approval, under the Generic Drug Fee User Amendments of 2012, or GDUFA, fee regime at the FDA, is perhaps also an indication that the FDA is making progress to clear its backlog of ANDA drug candidates under review. We regard it as hopeful that some of the Company's other 8 ANDA candidates will be accorded further attention soon. We are actively exploring the best approach to maximize our commercial returns from this new approval."
Keppra XR®, and the drug active levetiracetam, are indicated for use in the treatment of partial onset seizures associated with epilepsy. According to Symphony Health Solutions, sales in the United States for the 12 months ended December 2015 of the 500 mg and 750 mg strengths of Keppra XR® and all generic equivalents, were approximately $168 million (TRx MBS Dollars, which represents projected new and refilled prescriptions representing a standardized dollar metric based on manufacturer's published catalog or list prices to wholesalers, and does not represent actual transaction prices and does not include prompt pay or other discounts, rebates or reductions in price). The Company is aware that other generic versions of this product are currently available in the market. There can be no assurance that the Company's levetiracetam extended-release tablets for the 500 mg and 750 mg strengths will be successfully commercialized.
FDA Approved Two NDAs and Two ANDAs yesterday...
Maybe IPCI could be getting closer to the top of the pile for reviews? Wishful thinking I guess, but wanting to see one or more of the ANDAs approved by the end of the year...2010 was a long time ago!
Long IPCI!
Speaking of Top Line Results...Take a look at PPHM today...
Peregrine Pharmaceuticals Provides Update on Oral Presentation of Top-Line Data from Phase III SUNRISE Trial of Bavituximab
Already up over 30% within the first 30 minutes of trading!
We could see similar results when our TOP LINE Data is released!
Best of Luck!
No surprise with the quarterly loss, getting closer to NDA submission and wrapping up the results of the Phase III study. Costs a little more to have an outside agency compile your data so that it isn't flagged for purposely inflating the results in your own favor...I'm sure those stats companies are not cheap!
But, when it is all said and done, a lucrative partnership could be coming very soon...most likely prior to end of year! Could really get this stock moving back over $1.00 and in full compliance with AMEX, and possibly future NASDAQ uplisting...here's to HOPING!
Only a matter of time My Friend!
Wow, just heard it on the conference call....partnering between the release of top line data and NDA filing!
Top line data is expected by end of this year, and NDA filing is expected by mid 2017...not much longer to wait for this to really take off!
Good Luck Everyone!
True, they are going to need help in manufacture and production...which is why I speculate a deal announcement very soon.
Upfront payment possibly upon positive phase III studies, or upon NDA submittal to FDA. Either way, I am positive they will receive an up front payment, along with milestone payments.
Good Luck!
Lets Hope Not!
Management believes that the Company’s existing capital resources, together with approximately $8,500,000 received from the August 2016 financing, will be adequate to fund its planned operations through the quarter ending December 31, 2016. Assuming the double blind efficacy portion of the Phase 3 clinical trial of bremelanotide for HSDD is successful
Annual Report 10K is out!
http://ih.advfn.com/p.php?pid=nmona&article=72473053
A nice GREEN Day!
Here is to HOPING tomorrow is Super Green!
Good Luck!
$$$$ Amen to Jesus! $$$$
Thanks OleSkool!
Lots of good buying going on during this last hour of trading...
HOPE it is a hint of what is to come tomorrow!
Bring it on!
How could I be wrong on what I "Hope"...
Maybe you missed that part?
I can hope for the world, but get what I get!
Hell, we can hope for a 2.1 billion dollar buy out...LOL
Good Luck!
With the update prior to opening bell tomorrow, I certainly hope for good news. Positive results from the PHASE III, and an update to the expected NDA filing. I am guessing that the latest Cash raise was to fund the NDA application...a little over a Million for that, and the rest towards R&D on their other products in the pipeline.
Hopefully with tomorrow's announcement will be a lucrative deal/partnership with someone for the manufacturing and production of Bremelanotide. Upfront payments along with royalties announced for milestone sales.
Could really get this ball rolling!
Bring on the Good News!
New to the board here, and just started a small position today...may add over the next couple days prior to the conference on the 20th.
Definitely like what I am seeing and reading here! Can't wait till the top line results are posted, and the NDA is submitted!
Interesting Article!
http://www.investorideas.com/news/2016/biotech/09131PTN.asp
If even the most modest appraisals of HSDD's extent are considered, it is apparent that the condition is an unmet medical need that presents a multi-billion dollar market opportunity. The last Census Bureau (2010) figures indicate that there are some 60 million pre-menopausal women in the U.S. Consequently, the potential market for Bremelanotide could be at least six million and may be as high as 24 million. Palatin estimates a market size of eight million with anticipated sales of $1.3 billion by 2020.
Palatin has already completed enrolling patients in two North American phase III pivotal trials for Bremelanotide. All patient visits in these phase III pivotal trials have been completed and top-line results are expected late in the third quarter of 2016. The company expects to file a New Drug Application (NDA) for Bremelanotide in the first half of 2017.
Palatin has other promising drugs in its pipeline. PL-3994 is a candidate for improving treatment outcomes in heart failure. Two phase I studies have already been completed for PL-3994 and a phase II trial is at the point of starting. For treatment of a variety of inflammatory diseases, the company is working on a melanocortin receptor-1 (MC1r) peptide drug. MC1r may have application in the treatment of inflammatory bowel disease, nephritis (inflammation of the kidneys), rheumatoid arthritis, and certain ocular and dermatologic indications. In addition, a melanocortin receptor-4 (MC4r) peptide candidate has had clinical proof-of-principle established. Proof-of-principle studies are an early stage of clinical drug development when a compound has shown potential in animal models and early safety testing.
IPCI $$$
Absolutely,
With so many claiming to be standing on the fence waiting for the moment to jump in, this could get interesting very quickly. Hope SPROT covers soon, cause the momentum doesn't look like it is going to be stopping too soon!
Bring on the catalysts!
LONG IPCI!
Time to get this thing moving northward!
RSI is stabilizing, accumulation is increasing, audience is gathering...time to make the big announcement!
Long IPCI!
Speaking off ANDA's...
What ever became of the KEPPRA approval.
I understand that it is a relatively low market price of 151M, but it is something...maybe announce a small deal on that approval?
Anything would make the PPS spike up, especially right before the REXISTA Submission.
Long IPCI!
Just a little profit taking for those who bought in under $1.50...should cool down the RSI a little bit, then form a stable bottom to build from once those who sell are done. I look for more shorts to try and cover with this slight dip, and another good move up later this week or next.
Tic Toc...its August, and the filing deadline is on the clock!
LONG IPCI!
$$$ IPCI $$$ REXISTA ANY DAY NOW!
Dr. Isa Odidi, Chairman and CEO, stated, “The FDA waiver of the NDA application fee is a welcome decision in our development of Rexista™ XR. In addition, we believe the food effect studies demonstrate that RexistaTM XR taken under fasted and fed conditions is bioequivalent for all pharmacokinetic matrices studied and has no food effect, and that RexistaTM XR is well differentiated from currently marketed oral oxycodone extended release products, one of which is labelled to be taken with food due to food effects and the other whose Cmax matrix has been reported not to be bioequivalent under fasting and fed conditions. The Company plans to file the NDA for RexistaTM XR in August of 2016.”
$$$ IPCI $$$ REXISTA ANY DAY NOW!
Dr. Isa Odidi, Chairman and CEO, stated, “The FDA waiver of the NDA application fee is a welcome decision in our development of Rexista™ XR. In addition, we believe the food effect studies demonstrate that RexistaTM XR taken under fasted and fed conditions is bioequivalent for all pharmacokinetic matrices studied and has no food effect, and that RexistaTM XR is well differentiated from currently marketed oral oxycodone extended release products, one of which is labelled to be taken with food due to food effects and the other whose Cmax matrix has been reported not to be bioequivalent under fasting and fed conditions. The Company plans to file the NDA for RexistaTM XR in August of 2016.”
$$$ IPCI $$$ REXISTA ANY DAY NOW!
Dr. Isa Odidi, Chairman and CEO, stated, “The FDA waiver of the NDA application fee is a welcome decision in our development of Rexista™ XR. In addition, we believe the food effect studies demonstrate that RexistaTM XR taken under fasted and fed conditions is bioequivalent for all pharmacokinetic matrices studied and has no food effect, and that RexistaTM XR is well differentiated from currently marketed oral oxycodone extended release products, one of which is labelled to be taken with food due to food effects and the other whose Cmax matrix has been reported not to be bioequivalent under fasting and fed conditions. The Company plans to file the NDA for RexistaTM XR in August of 2016.”
IPCI #18 on the Break Out Board!
Garnishing some extra attention! :)
Long IPCI!
I'm sure there will be plenty of profit taking for those who got in under $1.50, it should give the RSI a chance to cool off as well. Yes, it will be nice to see the PPS stabilize here until that Major Deal is announced! Then the Sky is the limit...those will be the days of $1.00 plus gains in a day!
Good Luck Everyone!
Long IPCI!
Those who are selling now will be Salty in a few weeks!
Ahhhh, patience will be handsomely rewarded!
LONG IPCI!
$$$ IPCI $$$ REXISTA SUBMISSION SOON!
Time for all those who have sold over the past three months to start buying back in. Looks like the bottom came in, and the swing is headed north. Between those who regret selling trying to buy back in, and the shorts hustling to cover, this thing should push north of $2.5 by the end of the week. Good things in the near future, Great things are on the outlook! Pushing over $3.00 and then $5.00 will allow major funds to start buying in!
Long IPCI!