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Fabius- I think the class action suit should go after IPCI's only asset. The approved ANDAs and pending ANDAs. The reason I say this is in bankruptcy IPCI has two major debts:
1. Odidi Loans
2. Class action suit that was recently settled but still pending approval. In all likelihood insurance covers most of this, but some of it could fall onto IPCI.
IPCI has no money, no real estate or anything of value. They have some used lab and manufacturing equipment but that is not worth much. Thus, I say go after the ANDAs. Why? They are the only thing of worth. Also to prevent Odidi from running off to China and being able to manufacture and profit all by himself.
When you think about it, it does sound like a scheme. He funded ANDA approvals through a pump and dump scheme with the likes of Wainwright, etc. He never commercialized them and made them appear worthless. He never bought a single share of IPCI with actual money. But he loaned the company money at 12% interest. This guy is no fool. He knows that all debt gets 100% paid out before a single penny of equity in bankruptcy. So the debtors will take all IPCI assets... So that pretty much leaves Odidi with whatever he wants.
Weezuhl- I think a good lawsuit would be for shareholders to sue for ownership of all the ANDAs. There is no money to be had from Intelli. The ANDAs are the only thing of value... And it would be nice to extract them from the company before bankruptcy as Odidi with his loans has first crack at any assets. Would it not be criminal if in bankruptcy the guy who drove this company into the ground walked away with all the assets?
aelmtpa- I guess I will watch where ELTP goes next. That being said, don't celebrate and don't bet the farm on them getting approval. They were already denied at least once before and in general opioid approvals are very hard to come by. I am just a realist. I gave IPCI a 5% chance of approval before everything came to light. You might want to listen to the ADCOM board comments. The standard for approval is a moving target that gets harder and harder each day. FDA past guidance is obsolete and the approval question is do the benefits outweigh the risks? And panel attendees as much said they are evaluating as do the benefits GREATLY outweigh the risks.
DR Ryan- Agreed... Opioids are not getting approved unless it is something really innovative where benefits strongly outweigh risks. Intelli drug was not even close to approval. For investors in competitors, please listen to Intelli ADCOM. Certainly this ADCOM was not good news for you guys. And celebration of this denial will be shortly lived as your companies products will likely see similar fates in the future. Intelli even showed no food effect. The panel did not even care about this. But it was reason enough to deny other drugs in the past...
Wish you the best too Fabius
If its easier to manipulate, I really question why they proceeded with the application. Odidi may have even outdone himself...
Fabius- How were the studies incomplete? I think they did all the required testing. Its just that more studies were done on IV as they are going for abuse deterrent IV labeleing. I think they ran the requested tests for oral and nasal. Maybe they cut corners but I am not sure??? The oral and nasal results were not spectacular but mostly inline with ADF Oxy. I think where they fall short is when the panel is asked the question do the benefits of this approval outweigh the risks? I think the benefits are:
1. Superior IV ADF performance.
2. No food effect.
Risks:
1. Oral and Nasal ADF performance in line with ADF Oxy.
In looking at that, I don't think panel says benefits outweigh the risks as ADF Oxy is not a drug with a spectacular track record.
Fabius- If this gets voted no... I suspect nobody will ever fund the company again. I guess then Odidi can run off to China with his ANDAs. Any normal person could profit off those. But I am sure Odidi will totally screw that up as well. He is Odidiot...
Blue- Agreed, if they get their ass handed to them again, I think this company is done. Let's hope they have a plan going into this thing... I don't see how Odidi can say the oral and nasal results are better than ADF Oxy. I think he is going to just going to have to say they are in line with ADF Oxy. But the IV results are superior to everything else. And there is no food effect. I think that is the only plan of attack.
Honestly, I am not sure on how Intelli plans to spin the results. I think most look in line with ADF Oxy. Some results a little worse, some maybe a little better. So will their game plan be to try to sell this on no food effect? Good IV ADF? And say the oral and nasal results are in line with ADF Oxy? I am wondering what their game plan is?
Fabius- I am reasonably certain Odidi will be the voice of Intelli at Adcom. That is most of the problem with Intelli- Odidi has too much control. Why is he presenting? I can only think of these two reasons:
1. They don't have the money to hire someone who is qualified.
2. Pure arrogance on Dr Odidi's part.
Weezuhl- Will you be attending the Intelli Adcom next week?
Fabius- Good luck to us... For once I would like to see something go right for Intelli. For once I would like to at least see Odidi go into this Adcom prepared. I hope he is not too arrogant to have not learned from the last Adcom. I hope him and others are approaching this meeting very strategically. Lots more than science at Adcoms...
Mike- I am holding through adcom as I have already lost a ton here. There will no doubt be some Adcom attendees- paid by the competitors- badmouthing the product. Intelli is just a small guy and those corrupt Drs, etc. will do their best to hijack the meeting. One thing this product has is no food effect. None of the Oxy ADF competitors can claim this. Collegium has arguably the best current product on the market and their product has food effect. So I hope IPCI can shift the discussion to this big feature.
Mike- I am not sure this will not go through. But opioid approvals are hard to come by these days. Also I have watched Dr. Odidi for several years and he has a track record of poor applications, delayed approvals and poor management in general. I want this approval as much as anyone but I am just being realistic. I also don't want people to get sucked into the short seller trap. Those guys with the warrants are out there trying to sell shares. And they will burn this thing down if Adcom does not go well. Anybody who is considering buying should know that if Adcom does not go smooth, in a matter of days or hours this will be trading at 10 cents or less. So know the risks before you buy this and hold through Adcom.
Anymouse- I know you don't want to hear from me. But be careful here. The company has virtually no cash. NDA approval is a longshot but if approved this will fly big time. If not it will be sub 10 cents. And you might wonder why I am still here? I hold shares that I have lost over 95% on. So I would like to see this soar as much as anyone. But I am also a realist as I have seen Odidi fail, fail and fail some more over several years...
Lastly, there are about 17M warrants at 75 cents held by the lowest of the low pump and dumpers Odidi associated with. Don't think that is an insignificant data point in your research. Don't believe me? Research it.
To be honest, I think IPCIF should try to find some funding before ADCOM. Hopefully they can deal with a friendly partner that is willing to invest in the company. I say this because they have a history of dealing with shady and ruthless financing characters... I have no doubt those 75 cent warrant holders are shorting every share they can right now. And it is there plan to burn this thing to the ground and cover at 5 cents if Adcom does not go perfect. All that being said, I am not sure they can find an investor at this point. I think most real investors would be scared off by Odidi's terrible management of the past. If Odidi would just step down as CEO, they may have better options.
Fabius- I think someone at Adcom mentioned they owned stock in ELTP. But I believe there is more there than that...
Lex- 100% agreed. I really think that the last Adcom room was loaded with people that represented companies that had vested interests in IPCI not being approved. Competitors is pain space... I don't think this time will be any different. Let's hope IPCI is prepared. If I was at IPCI, I would have had every single person in the room at last Adcom researched extensively...
Fabius- I hope the dream comes true... I give it 5% for approval but a positive Adcom could really make this thing run...
Could be some small time players that try to hold a short without warrants through Adcom. When you think about this, it is a good bet, but in the event of positive results and positive panel vote, they may end up covering at $5, $10 and maybe even $20 per share.
Will be interesting to see who shows up at Adcom… I think it is worth investigating these participants to see if they have "conflicts of interest" in regards to their testimony...
Fabius- one more thing. In my opinion the volume the last two days is fake. It is just our old friends wash trading this up in price to get ipci on people's radar. Then the pump will start going into adcom.... Lastly, they will dump as many shares as they can as there is no risk as they have the warrants.
Fabius- I would love to see a squeeze here but patient and odidi screwed up royally by issuing those 17M warrants are .75. The guys that hold those warrants are in control and an approval would drive a big increase in pps while those scumbags sell and sell and sell... Then reality sets in and they exercise those warrants and the float goes up big time. Odidi is such an idiot for selling all those warrants. The guys that hold them will make money in both scenarios. And if they don't get approval, odidi can sit back and watch those scumbags take the pps to sub 10 cents.
Here is my opinion on what warrant holders are doing
1. They have been and will continue to short sell as many shares as they can. The likelihood of approval is low and no approval this goes to .10 or less. If approval, they use 75 cent warrants to cover the shares they sold.
2. If approved, they will continue to short sell as many shares as possible and then cover at 75 cents for a huge profit. Approval Will lead to huge pps increase but odds are 5 percent or less.
I told penna, odidi, patient that the warrants are bad for the company. Last offering the warrants were an absolute joke. Now the guys that burned ipci to the ground will have profit again on these ridiculous warrants. And they wonder why they can't book an offering...
I think there are about 15-17 million warrants at 75 cents. So who owns those and what happens if this ever gets there...
I hate to rain on anyone's parade but here is the truth about Intelli:
1. They are in desperate need of cash. They are barely making payroll and paying bills. They have been trying to secure financing for some time but this company has a very poor history because:
a. Their approvals always came late.
b. They could not monetize approvals
c. Market vision within company was poor and ideas always came to market way too late
d. They never reached cash flow positive status despite repeated promises.
e. They paid the bills by diluting over and over again. They used the same crooks every time to accomplish this. Sabby, Anson, others... The crooks finally put the screws to them and to try to preserve NASDAQ listing they did a 10:1 reverse split. It did not work and the crooks drove the PPS into the ground- sub $5M market cap.
2. Their NDA that has an ADCOM in January is for an abuse deterrent opioid- Oxy clone. Opioids are frowned upon these days. So it would be a major miracle if they get approval. I would say less than 5% chance. But if it does get approval, PPS should skyrocket. Just realize it has a very low chance of approval.
3. Shareholders have been majorly screwed by the company. In particular the Odidi's. Research how many shares the Odidi's ever paid for- exactly 0. The Odidi's have screwed this company over by their poor leadership and the only money they ever put in was in the form of 12% loans- that the company is still paying off... And yes these loans did not get hit by the 10:1 reverse split.
4. The Odidi's hold the only debt this company really has. Remember debt gets paid out before equity in bankruptcy proceedings... I think when this company does go bankrupt, the Odidi's will walk away with the ANDA approvals and all shareholders get screwed once again...
5. The Odidi's also secretly set up a Chinese pharmaceutical manufacturing company that is not connected to Intelli. When this became public, I personally told Odidi this was a conflict of interest. But that **** was too arrogant and greedy to see the truth here. So put two and two together- who benefits in bankruptcy when they walk away with the ANDA approvals... Certainly not the shareholders.
I know ipci got beat up about the blue dye. But in reality it could be a good deterrent for abuse. They should of run the studies on this aspect to show it's not a problem, etc. It could certainly be a road to approval when opioids are being scrutinized.
The ADCOM has a date:
https://www.intellipharmaceutics.com/news-media/press-releases/detail/216/intellipharmaceutics-announces-fda-advisory-committee
Anybody feel there is any chance for approval? Oxy has such a bad rap these days, I just wonder if the FDA can even consider approving anything Oxy? The one wild card her is this is an abuse deterrent for of Oxy. Maybe just maybe if the features are good enough they could get and approval????
Trend- yes there is a period where people who bought shares are entitled to a portion. I have not received anything yet. I will try to track down samsa and see what are the details. If you are really interested in this contact the lawyers. My guess is they will try to keep as much as they can and leave shareholders with scraps.
Intellipharmaceutics Update on its Oxycodone ER New Drug Application
Download as PDFOctober 24, 2019
TORONTO, ON / ACCESSWIRE / October 24, 2019 / Intellipharmaceutics International Inc. (OTCQB:IPCIF and TSX:IPCI) ("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 today that it has been advised by the U.S. Food and Drug Administration ("FDA") that product specific advisory committee meetings for opioid analgesics, as related to Intellipharmaceutics' Oxycodone ER New Drug Application ("NDA"), which were previously postponed, as announced on July 24, 2019, are no longer on hold. The Company is pleased with this development and is prepared to attend any advisory committee meetings in the future.
We anticipate that the FDA will take action regarding approvability or otherwise, on our application, after the advisory committee meeting is held for Intellipharmaceutics' Oxycodone ER NDA. However there can be no assurance of the timing of an action being taken, as there are many factors that may affect when the FDA may take action.
There can be no assurance that an advisory committee meeting to discuss our NDA will take place in the foreseeable future or at all. There can be no assurance that Intellipharmaceutics will not be required to conduct further studies for Oxycodone ER, that the FDA will approve any of the Company's requested abuse-deterrent label claims or ultimately approve the NDA for the sale of Oxycodone ER in the U.S. market, or that it will ever be successfully commercialized.
About Intellipharmaceutics
Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company's patented Hypermatrixâ„¢ technology is a multidimensional controlled-release drug delivery platform that can be applied to a wide range of existing and new pharmaceuticals. Intellipharmaceutics has developed several drug delivery systems based on this technology platform, with a pipeline of products (some of which have received FDA approval) in various stages of development. The Company has ANDA and NDA 505(b)(2) drug product candidates in its development pipeline. These include the Company's abuse-deterrent oxycodone hydrochloride extended release formulation ("Oxycodone ER") based on its proprietary nPODDDSâ„¢ novel Point Of Divergence Drug Delivery System (for which an NDA has been filed with the FDA), and Regabatinâ„¢ XR (pregabalin extended-
Looks like Odidi once again listened to no one. The price action shows they are going to sell more than 75% of the company to net $3-4M. This once again is a desperate move and it will only allow them to operate for 3-6 months. I think after this money is gone, Intelli is done for good.
Lastly, who in their right mind will buy this offering? I am guessing they plan to shut Intelli down and sell everything off once the deal is done. There could be no other reason to invest any reasonable amount of money in this company at this time. Odidi has failed as a:
1. CEO
2. Scientist
3 And most importantly as the Intelli market visionary. Every one of his products were so late to the market he could not capitalize...
Odidi is total failure!
They partnered another ANDA. Market is yawning because these should have been partnered long ago. Intelli should not go to the capital markets and sell 60-75% of the company to keep operations going for another 3-4 months. That is just another slap in the face to the shareholders who have repeatedly been diluted out from mismanagement by the Odidi's. How about they reduce the executive staff? Get rid of COO position and VP of Commercial Operations. This company has virtually no revenue and very few prospects. But they have a very overweight executive staff that is ludicrous for a company of this size and revenue.
Numbers- In my opinion, I think the FDA has already responded to IPCI and said it needed to re-evaluate approval criteria for opioids like Oxy... My guess is whatever they decide, this product will be left in limbo because the FDA will move at a smail's pace on this. And when they decide how to evaluate these drugs, I am sure it will have additional criteria, etc. that IPCI's application does not cover or meet. Bottom line is Rexista is a dead product... I blame Odidi. He submitted a half ass application that did not include oral or nasal HAP studies. He is a moron for thinking that would fly. If he had submitted a complete application, he might have got approval the first time through... But he didn't... Now he can push blame on FDA and say they changed the rules on us. But bottom line is if he would have submitted a complete application first time around, maybe he would have gotten approval.
Yes, Purdue is going bye bye. But I really wonder if the Sackler family will end up paying out of their own pockets.
So where does this leave filings like Rexista? Rexista is supposed to be abuse deterrent... But what does abuse deterrent mean? The FDA does not even know. So now the FDA goes and forms a committee to develop guidelines for what abuse deterrent is. This will take years... And applications like Rexista will just sit in limbo for years...
The big question is how IPCI now stays in business? Who in their right mind will invest in them? And if they can find some scoundrel to help them with the offering, my guess is they sell 50M shares at $0.10 to net about $4M... So they will sell two thirds of the company to keep the lights on for another 3-4 months... How can the Odidi's look themselves in the mirror and tell themselves they are doing a good job? Or even an OK job...
Fabius- Why on earth would anyone give him money? If he wants to make this company work, he is going to have to deliver revenue to pay the bills. I remember the revenue estimates a couple years ago just prior to Seroquel release. IPCI missed on those big time and he did nothing to right the ship. So can he partner everything and come up with $1M per month in revenue to sustain his burn rate? My guess is no.
Well it looks like they finally found a partner for one ANDA:
https://ir.intellipharmaceutics.com/press-releases/detail/208/intellipharmaceutics-signs-an-exclusive-license-and
Now what about the rest?
Doog- I still don't think Odidi grasps what has happened. Bottom line:
1. IPCI has virtually no revenue.
2. Rexista is dead even though they still try to convince themselves the FDA is actually still considering that NDA.
3. They have several ANDA approvals they can't commercialize and they still feel a profitable deal will happen. Better than 95% chance it won't.
I have no idea on what is going on inside of IPCI. Pretty much nothing in my opinion. It is a second rate, garage shop pharma where the market visionaries have no clue what the future markets are... The big question is how do they continue with their $1M+ per month burn rate and no money or prospects for money? I think the answer is they can't for much longer.
It will be interesting to see what Odidi's plan is to keep this company going. I really do not see how he can pull this off for much longer. I mean what is the hold up on the ANDA deals?
We all know Rexista is pretty much totally dead now... So what is the future of this company? What is he going to try to sell as their new pipeline? There is nothing left...
dontknowsht- Personally I feel the Rexista approval is a long shot for two reasons:
1. Odidi has received CRL after CRL on ANDA after ANDA. His approvals always come very late. In my opinion, I feel he puts together rushed and half ass applications that have many flaws.
2. The political climate around opioids make approvals in that space hard to come by. IPCI is a very small company and unless their abuse resistance is very strong in all categories, I feel the FDA will rubber stamp it denied. In particular, oral abuse will be a key deciding point. If those results are strong, they could very well get approval. But they have not released the HAP results, so we have no idea what to expect.
I would like to see an approval as much as anyone. That way I might be able to recoup some of my losses. This approval is a longshot and I would say less than 5% chance.
Numbers and Weezuhl- I would love to see Intelli gain an approval for their Oxy ER(Rexista). However, I am a realist... In my opinion, the only way they get approval is with stellar oral HAP results. But based on Odidi's track record of poor applications, CRLs, etc., etc. I would say they have less than a 5% chance of approval and more than a 95% chance of denial. But like I said, it will be based on the oral results... Which they have not published... So place your bets... This is a long shot... But in the event they do get approval, this will run hard. But the odds are more than 20 to 1 against.
Fabius- For once, I would like to see a revenue generating deal. One that can sustain the company for a good while- not just three months. There has to be some way to generate money off the ANDAs. I am not sure why they sit shelfed... I still wonder why the company has 50 employees. If they are doing research, what are they doing research on?