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Fabius - you are right both patient and odidi have no concept of basic math applied to dilution and offerings. They just don't get it... Total idiots. And I really question patients qualifications but something tells me he is just following orders.
Fabius - that is odidis biggest fault... He listens to no one. He had many options and many things he could of advanced but he listened to no one and did exactly what he wanted. Now look what happened... He makes so many assumptions based on best case planning and outcomes and it always turns out to burn him. He is in the process of diluting out long term shareholders to keep doors open for six months. I get the feeling after those six months are up he will be letting all his employees go and closing up shop.
Lex- this is it if he does not have anything substantial to announce.
I mean this offering is his last attempt to save company. Many people suggested to him to sell some assets off and partner things. But he refused to listen... Now he feels it is prudent to sell 2/3 of company for maybe $10m. I guess he just wants to collect his salary to the bitter end.
Samsa after today he will update filing to say 14m shares...
The only saving grace in all this it is a real dose of humble pie for odidi. I can accept failure but I can't accept arrogance and lack of effort.
Well if no rexista partner it is a scam
As usual doog some one knew yesterday that hap studies were done and details of the offering.
The momentum sheep will be slaughtered two days in a row. Boy are people on stock twits idiots
You got your results odidi, right now would be time to partner rexista... But he won't because he knows it all...
If anyone wants the pos known as ipci they can now by 66% and full control for $10m.... But some how I don't think any wants to inherit this train wreck.
And Dr odidi... If you actually believe in your self lay down some of your cash... But we all know he won't. This whole offering is just to give him six months to close the shop and sell his house in Toronto.
So Mopar the question is now how long to analyze and write up study info?
Take a look at volume plot today. Morning extremely high volume and price went up. Then in the afternoon volume subsided and it went down on relatively low volume.
Anyone notice that the big volume happened in the morning and the price rose. Then this afternoon volume subsided and it was taken down on low volume. That could mean many things but thought I would share.
Fabius- Unbelieveable. I guess Odidi being paid back for dealing with bottom of the barrel finance houses. That is what this is about... 50% that and 50% that he never advances anything. Totally inept with everything.
Amherst- You have mail
Amherst- I would be interested to hear how we can pressure him. He just ignores shareholders for the most part right now.
Fabius- I agree, Odidi needs to take a good hard look at himself and admit he failed and it is time to step aside. I mean just compare what they promised in January 2018 to what they have accomplished thus far. Add to that the PPS is in a free fall and the company has no money or source of income/funding. He needs to take a dose of humble pie and get off his high horse... He should watch the interview he gave after getting listed on NASDAQ. He said the company would be worth $500M-$1B by 2015(going from memory but should be close). He surely has failed and by him clinging on to the CEO position he is just showing his stubbornness and arrogance.
Blue- IPCI won't last another year. They just can't advance anything. And that is the #1 problem. This next dilution will pay the bills that are stacking up and maybe take them to March 2019. When I took the survey a year ago I said the biggest problem was they did not partner anything and could not monetize their technology/approvals. I really stressed this when I talked to Patient for the first time as well. One year later, same old same old.
Blue- Personally I won't touch that stock because I know who is trading it and facilitating offerings. CLSN has this in common with IPCI:
1. Wainwright
2. Anson
3. A little research and you will find another commonality
Good luck with it. And if they have successful trial you will make a bundle.
Samsa- The BOD is a joke. It is the Odidis and a couple of their buddies. They won't do a fricken thing. The only hope is after next offering, all owners get together and start the process of removing him. It will all depend on who buys next offering. They will get it so low that they will give Odidi a chance. So that puts off the removal... Unless someone who already wants him out buys it. But I don't see that happening.
CLSN is a cancer drug development company. Better than 90% chance your investment goes to 0. Less than 10% chance you hit a 10 bagger. Extremely high risk. Very small chance it is a lottery ticket.
Blue- If you haven't noticed... Some of the same people that invest in IPCI have rode CLSN through a RS, etc. Just making sure you know that as soon as one of those trials fails, they will beat that thing down as hard as they can.
I looked on Sunday and though Tecfidera was one for MS
Blue- CLSN- you make me laugh... That is another pump and dump... You cannot be serious.
Tilator- I meant International markets that accept FDA approval. My mistake.
If you look at the January operational update, the only thing they delivered on was starting Rexista HAP tests... And they started those late... Then if you look at the FREE WRITING PUMP they pretty much said the same thing but just kicked the can down the road... Odidi should be a frickin politician... Also note in the latest PUMP that they did not say anything about starting Regabatin studies... At this point, Odidi will need to sell the entire company to get his $10M... He is a comedian talking about his 3 new NDAs... So what... They are nothing more than proof of concept that nobody will partner and will never advance!
evenkeel- Yes, so please share and save me the effort. That's why the confidential statement is ridiculous... With a little work you can figure it out so it is not confidential...
For your reading pleasure:
[/2017 key operational highlights include:
•Intellipharmaceutics commenced in-house manufacture of its first commercial product (all strengths of generic Seroquel XR® (quetiapine fumarate extended-release) tablets) for export to the United States.
•Intellipharmaceutics’ marketing and distribution partner, Mallinckrodt LLC (“Mallinckrodt”) launched all strengths of generic Seroquel XR® in the United States, providing us with the full line of generic Seroquel XR® strengths available in the U.S. market.
•Our marketing partner, Par Pharmaceutical, Inc. (“Par”) completed the launch of all strengths of generic Focalin XR® (dexmethylphenidate hydrochloride extended-release) capsules in the United States, providing us with the full line of generic Focalin XR® strengths available in the U.S. market.
•The United States Food and Drug Administration (“FDA”) accepted for filing our new drug application (“NDA”) seeking authorization to market our Oxycodone ER product candidate in the 10, 15, 20, 30, 40, 60 and 80 mg strengths.
•We received a complete response letter (the “CRL”) from the FDA providing certain recommendations and requests for information regarding our Oxycodone ER (formerly known as Rexista™) NDA.
•We received final approval from the FDA for our abbreviated new drug application (“ANDA”) for metformin hydrochloride extended release tablets in the 500 and 750 mg strengths (a generic equivalent for the corresponding strengths of the branded product Glucophage® XR sold in the United States by Bristol-Myers Squibb).
•The Company announced the grant of additional U.S. Patents in respect of “Compositions and Methods for Reducing Overdose”, covering aspects of the Company's Paradoxical OverDose Resistance Activating System (“PODRAS™”) delivery technology, which is designed to prevent overdose when more pills than prescribed are swallowed intact.
Drug Portfolio Update
Oxycodone ER Abuse-Deterrent Program
The Company’s NDA for an abuse-deterrent version of Oxycodone ER was accepted for filing by the FDA less than twelve months ago. The submission was supported by Category 1 abuse-deterrent studies (to support intravenous abuse deterrent label claim) and pivotal pharmacokinetic studies that demonstrated that the product is bioequivalent to OxyContin® (oxycodone hydrochloride extended release) and can be administered with or without a meal (i.e., no food effect).
The joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the FDA held in July 2017 expressed a desire to review additional data for Oxycodone ER that may be obtained from human abuse potential studies for the oral and intranasal routes of administration. The CRL from the FDA received in September 2017 clarified concerns expressed by the advisory committees and the path for resubmission of the application. Subsequent to receiving the CRL, the Company immediately began preparing its response, including finalizing protocols and plans to complete the Category 2 and 3 studies to support the application.
The planned studies to support both the oral and intranasal route of abuse-deterrent label claims are scheduled to commence within the next few weeks and expected to be take approximately six months from commencement. We anticipate that the NDA will be resubmitted to the FDA in late summer 2018. As previously announced, as a result of the patent infringement proceedings against us in the United States launched by Purdue Pharma L.P. et al (collectively, “Purdue”), the FDA is stayed from granting approval of our Oxycodone ER product until August 24, 2019 unless the court declares Purdue’s patents to be invalid, or not infringed; or the matter is otherwise settled among the parties. The Company believes that it does not infringe the subject patents and that it has a well-prepared strategy to vigorously defend against the claims. A trial date for Purdue against the Company regarding the product has been set for October 22, 2018. With a resubmission of the NDA ahead of this date, the Company anticipates that it will remain on its original schedule with respect to commercialization at the earliest possible opportunity.
Intellectual Property Portfolio
PODRAS™ Technology
Intellipharmaceutics continues to make progress regarding its PODRAS™ delivery technology, recently obtaining three additional patents from the U.S. Patent and Trademark Office (U.S. Patent Nos. 9700515 and 9700516 in July 2017 and No. 9,801,939 in October 2017) also entitled "Compositions and Methods for Reducing Overdose" and covering aspects of the Company's PODRAS™ delivery technology. The Company is optimistic about the prospects of this technology, which deliberately regulates the bioavailability of active ingredients in both generic and non-generic medications in a way that reduces the opportunity for overdose and/or abuse. The Company is finalizing plans to initiate proof of concept trials in humans. The Company believes that the preclinical work on the technology to date has shown encouraging results, but human trials are required to show that the technology works as expected. The human studies for PODRAS™ are expected to take place in the first half of 2018. Based on the results of these studies, the Company will evaluate commercial opportunities for the technology including potential out-licensing as well as incorporation into products within our pipeline.
Drug Development and Commercialization Progress
Generic Seroquel XR® and Generic Focalin XR®
Intellipharmaceutics’ marketing and distribution partner, Mallinckrodt launched all strengths of generic Seroquel XR® (quetiapine fumarate extended-release tablets) in the U.S. in June 2017. With the launch of two additional strengths of generic Focalin XR® (dexmethylphenidate hydrochloride extended-release capsules) in November 2017, the Company’s marketing and distribution partner, Par has now launched all strengths of generic Focalin XR in the U.S. Intellipharmaceutics continues to work with Mallinckrodt and Par to gain traction in the competitive U.S. market, and is actively pursuing opportunities it has identified outside of the U.S. to expand global market reach.
Regabatin™ XR
The Company has had in development a once-a-day non-generic controlled release version of pregabalin (marketed in the U.S. by Pfizer under the Lyrica® brand) under the NDA 505(b)(2) regulatory pathway, with a view to possible commercialization in the U.S. at some time following the December 30, 2018 expiry of the patent covering the pregabalin molecule. Regabatin™ XR is based on our controlled release drug delivery technology platform which utilizes the symptomatology and chronobiology of fibromyalgia in a formulation intended to provide a higher exposure of pregabalin during the first 12 hours of dosing. The FDA has recently approved Lyrica® CR, a branded controlled release formulation of pregabalin. The Company believes its product has significant additional benefits to anything currently on the market and is very excited to continue development of its formulation. We are currently evaluating partners for required Phase III studies and expect to begin these studies in the second half of 2018.
Other Products and Markets
Intellipharmaceutics continues to pursue partnering opportunities of its other ANDA, Abbreviated New Drug Submission (“ANDS”) and NDA products and product candidates, both in the U.S. and internationally. The Company has a strong pipeline of ANDAs. Two ANDAs have recently been approved and others are in various stages of the FDA review process. While commercialization opportunities for our product have been challenging in the U.S. due to the extremely competitive cost environment, the Company has been working with its supply partners to reduce input costs and achieve efficiencies which we expect to lead to new opportunities in the U.S.
In addition, the Company continues efforts to identify opportunities overseas, including in China, that could if effectuated provide product distribution alternatives through partnerships and therefore do not require an investment or asset acquisition by the Company. The Company recently visited China where discussions toward establishing a partnership to facilitate future development activities are ongoing. The Company has not entered into any such arrangements at this time. These opportunities could involve out-licensing of our products, third-party manufacturing supply and more efficient access to pharmaceutical ingredients and therefore assist with the development of our growing product pipeline.
As the Company builds its product portfolio, we are also seeking to add additional product development candidates to our pipeline. We have received considerable interest and are investigating several opportunities to develop products in collaboration with international partners.
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Samsa, Fabius, Tilator- Here is what I see differently:
1. The latest prospectus says PODRAS human results Fiscal Year 2018. All I know is that I was told by Patient that these were being started many months ago... And they would not take long and mid year for these results. So once again they failed to deliver results in a timely manner.
2. I was certainly under the impression they would partner Regabatin in mid 2018... And they certainly led me to believe this was likely to happen.
3. I was told specifically that packaging tests for European markets were underway. And these markets would accept FDA approvals. I was also told these were low volume, high margin products to be manufactured in Toronto. I was led to believe they would start seeing income on these late 2018. I was told it would not be much but it would help nonetheless... Now it appears 12-24 months????
4. I was told years ago two products are very close to approval. I was told this by Penna in 2016 and again by Patient in late 2017.
I have an example that completely shows the problem with IPCI.
They list potential markets for Regabatin as $4.57B... Yet, they have not advanced that product since August of 2015. At that time they filed an IND on Regabatin with the FDA. That is the last progress on that drug... Yet they continue to say it is part of their pipeline. That is totally misleading. Bottom line... They have a prototype of a Lyrica XR knockoff that they ran some in house tests on. They filed an IND in 2015 and nothing more...
The Odidi's are amateur scientists and business people that in my eyes appear to be very arrogant and lazy. They just cannot get the job done. They think their technology is special and worth so much. Yet no one wants to license or partner it. They are an absolute joke of a company. The market is speaking. It is telling the Odidi's if you want your next tranche of $10M we want 75% of the company and warrants to boot. I am guessing King Odidi thinks he is not being given a fair shake. But I wonder if he ever looks in the mirror and sees that he has mislead his shareholders for the last 5 years. He sat back, pumped his ego and lived a lavish lifestyle. All the while not doing his job. The reason the company trades so low is he never was able to get the approvals. He never partnered any of his drugs. He never did the work to break into new markets. He never licensed out any of the patents/IP. He had many options on how to grow and build this company but he sat back and did nothing. He paid the bills by one financing after another. Now is the day of reckoning for Odidi. He had all of 2018 to right this ship but he once again did nothing. So what will he do now? He will do the only thing he knows... Massive dilution...
wimike- exactly...
wimike- Hasn't the burn rate always seemed real high for what they are doing? Just an idea... But maybe it really never was that high and someone has been embezzling all along... Never know.
wimike- I do believe Odidi would like to move this to China. But he was caught with his hand in the cookie jar and the China fiasco is now in the current litigation records. He won't be able to do that any time soon.
BTJ- I hear you. Because nobody could be as stupid as they are... But, they are that stupid! Unbelievable.
BeJw- I am at the same point as you. I ain't going to throw in the towel now. But I probably end up losing it all... Not much left at this point. Lastly, Odidi will never sell a single share of worthless stock in China. If that is his plan... That will be my revenge on Odidi for being the con artist he is.
Many people could buy out IPCI but there is a reason they don't... There is nothing there at all except an arrogant SOB hanging on to a failing company by a thread.
Fabius- Patient has really been a bad CFO as well. I know he was dealt a bad hand. But he should of pushed back on Odidi to do something or he would be forced to sell the whole company for $10M. Odidi was too arrogant to realize this day was coming. But market is saying, you have not done anything in years, why should we trust you with more money?
wimike- You don't need new rods, you need to get out fishing!
Lex- I love it... I mean nobody buys the three new NDAs... It is just a joke and scam. I mean... If you can't do anything with Regabatin in five years, what can you do with those drugs?
wimike- I am sure they are still up and running. Pretty pathetic that he will need to sell more than 50% of the company to get his next $5M...