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Jan. 10, 2020 9:45 AM ET|About: UnitedHealth Group Inc... (UNH)|By: Douglas W. House, SA News Editor
•FDA advisory committee meeting on Esteve Pharmaceuticals S.A.'s celecoxib 56 mg tablet for acute pain (morning session) and Intellipharmaceutics' (OTC:IPCI) extended-release oxycodone for the management of moderate-to-severe pain.
IPCIF =Price 0.28--MC $7 M --ADCOM meeting mid next month --Abuse Deterrent Pain Drug =2000% POTENTIAL if positive outcome...Drug has $400 million commercial opportunity = A MEGA LIFETIME OPP ..RALLLYYYYYYYYYYYYYYYYYYYY
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.
So what? I like the majority of most former IPCI s/h's sold this dog crap way before their last gasp reverse split of a full year ago when it became apparent that this clown CEO was clueless as they come on how to extract a single shred of relevant value from their totally useless ANDA or NDA pipelines lol!
But thanks for playing bwahahahahahhahahahahahaha dooooooooooohhhhhhhhh
doogdilinger Tuesday, 07/17/18 02:18:10 PM Re: wimuskyfisherman post# 35758 0 Post # of 38619
Yep Odidi's a total incompetent disaster PubCo CEO. He severely lacks any vision and for all the potential of his science he single-handedly destroyed it. I doubt this company survives another year and then Odidi will simply claim bankruptcy and run over to china and Nigeria taking all his dilutive financing tricks learned with him lol.
Monster SunGen ANDA Approval in 2019 will get is CFP early 2020. The GrandDaddy of the SunGen ANDAs in 2020 will have Elite bulging with revenues. These two products hav over $3 billion markets
Based on the lawsuits for JNJ, TEVA and others, it's a dead end to try and get this approved. The FDA probably won't approve anything for years now, no matter how good it is.
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’s (“FDA”) that the FDA “is postponing product-specific advisory committee meetings for opioid analgesics,” including the one previously scheduled to discuss the Intellipharmaceutics New Drug Applications (“NDA”), “while it continues to consider a number of scientific and policy issues relating to this class of drugs.” According to the FDA, the reason for the postponement is not unique to our product and the Anesthetic and Analgesic Drug products Advisory Committee (“AADPAC”) meeting earlier planned by the FDA, to discuss our NDA will be rescheduled at a future date. ************ The FDA strikes again.
IPCI's Ranexa NOT among 2 additional Approvals 7/5/2019. GlenmarkPharms got approval on July 5, 2019, last week. SciegenPharms got approval in June 2019. So now there are a total of 7 ANDAs for Ranexa. I hope IPCI gets approval soon, and not years late.
PDUFA is 47 days away on May 28, 2019. I still have not heard of any FDA AdCom (Advisory Committee) meeting scheduled yet.
Intellipharmaceutics International Inc. Announces $10,000,000 Equity Financing Commitment During the 36-month term of the equity financing commitment, Intellipharmaceutics may sell shares of its common stock to Silverback Capital up to the $10,000,000 total commitment at a 25% discount to the volume weighted average price of the Company’s common stock for the 5 trading days prior to the date the Company provides notice to Silverback Capital, or if the maximum discount rate allowed by the Company’s principal exchange is less than 25%, then the maximum discount rate allowed. *************************************** This is the worst type of financing, because it incentivizes them to get the lowest share price so they get more.
Yep, non-stop dilution to keep paying IPCI's 50+ employees and BOD's for delivering nothing of any relevant value for 10 and a half years and counting, as IPCI remains stuck in its perpetual R&D phase lol.
At this point nothing IPCI informs the market can be relied upon as accurate because time has more than exposed Dr. Odidiot's ineptitude when it comes to dealing with the FDA.
And if there was a chance at success on IPCI's upcoming scheduled Aug 28th Oxycontin ER PDUFA date, one would think that the CAT 2 & 3 studies wouldn't have been kept hidden from the market.
So IMO only, the chances of IPCI's Oxycontin ER going the way Remoxy's gone over these past 10 years is a far more likely outcome than any magical surprise FDA approval at the end of August, as time has totally exposed Dr. Odidiot's ineptitude where/when it comes to advancing anything in this company's pipeline in an even remotely relevant fashion lol...and if it can go wrong, or be done incorrectly, we can be rest assured that that will be the most likely outcome here:)
In March of this year this is what IPCI claimed the FDA informed them>>>
The FDA has informed the Company that it considers the resubmission a complete response to the September 22, 2017 action letter it issued in respect of the NDA. The FDA has also assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2019.
And way back in September 2017 this is what IPCI claimed the FDA's CRL required IPCI to do>>>
Intellipharmaceutics complete the relevant Category 2 and Category 3 studies to assess the abuse-deterrent properties of Oxycodone ER by the oral and nasal routes of administration.
So why there's been no AdCom scheduled yet for the upcoming August PDUFA date is beyond me. And the even bigger mystery is why IPCI never bothered publishing their CAT 2 & 3 studies which they now claim the FDA considers a complete response to the Sept 2017 CRL the FDA issued IPCI.
And considering how long Remoxy's been at it(a full decade) and the 4 rejections Remoxy's received so far(as numbers laid out)...I definitely agree that the percentage for potential success is ultra-slim here considering what a train wreck this stock/company has been lol.
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.
You are correct that it will come down to the chewing abuse studies, but why would they not publish good results? If this runs up as the PDUFA date approaches, I wouldn't wait to sell the news. More like 1000 to one, but with the FDA, you never know.
An 505(b)2 NDA can be marketed as generic, in addition to name brand, if the FDA gives it a TE Code of AB. Since company is just calling the drug "Oxycodone ER", I assume that is the path IPCIF is seeking. If you look up an NDA there is a column for "TE Code" and Therapeutic Equivalents for NDA are listed at the bottom.
The link you provide is about IV drugs, so not relevant to this discussion. You might be confusing authorized generics. For example, Purdue actually does market an authorized generic version of OxyContin under their NDA, but that doesn't mean another company can do the same. If you are aware of any currently available tablet or capsule that was approved as NDA but is getting automatically substituted at the pharmacy as a generic for another NDA drug, please name it.
I assume FDA gives guidance on what abuse studies were required after the 1st AdCom. Did FDA say they needed a "successful chewing study" to get approved?
Yes, they did. They specifically have said that no new NDA's will be approved that are not as abuse deterrent as available products. For oxycodone ER, Xtampza sets the standard, not Oxycontin. Xtampza has the chewing label, so if FDA sticks to their published guidelines, no new NDA's for oxycodone ER will be approved without the chewing label.
I was just guessing no Advisory Committee meeting, since I have not heard of one scheduled yet. Does not FDA need to give company time to prepare for an Adcom and time for FDA to consider Adcom advice? IPCIF's 1st AdCom was announced about a month before the meeting and was scheduled about 2 months before PDUFA. It is getting too late to 2nd PDUFA date to schedule an AdCom.
I should revise what I said. The oxy ER will not be approved without an AdCom. No AdCom prior to PFUFA date for an opioid is typically not an indication of impending approval.
WeeZuhl, Oxycodone ER is generic chemical name. An 505(b)2 NDA can be marketed as generic, in addition to name brand, if the FDA gives it a TE Code of AB. Since company is just calling the drug "Oxycodone ER", I assume that is the path IPCIF is seeking. If you look up an NDA there is a column for "TE Code" and Therapeutic Equivalents for NDA are listed at the bottom.
WeeZuhl wrote: "As a result, their drug will need to prove abuse deterrence as good as all other NDA's, which means it will need a successful chewing study."
I assume FDA gives guidance on what abuse studies were required after the 1st AdCom. Did FDA say they needed a "successful chewing study" to get approved?
WeeZuhl wrote: "There most definitely will be an AdCom in order to discuss the nasal and chewing HAL studies, which were notably absent at AdCom #1."
I was just guessing no Advisory Committee meeting, since I have not heard of one scheduled yet. Does not FDA need to give company time to prepare for an Adcom and time for FDA to consider Adcom advice? IPCIF's 1st AdCom was announced about a month before the meeting and was scheduled about 2 months before PDUFA. It is getting too late to 2nd PDUFA date to schedule an AdCom.
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.
It seems Oxycodone ER is basically a generic of Oxycontin. I am guessing FDA will not hold another Advisor Committee meeting since is it so close to being a generic. All IPCIF has to do is show Oxycodone ER is equally as abuse-resistant as Oxycontin to get approved. IPCIF claims Oxycodone ER is bioequivalent with or without food so the drug meets the requirement to be generic AB-rated.
It is interesting to see others finally agree with what I was saying over & over, which is that Rexista is nothing more than a generic Oxycontin clone. I repeatedly advocated that they withdraw the NDA and submit an ANDA for generic Oxycontin, but they didn't. They continue to pursue this drug via the NDA route, which is important for multiple reasons. First and foremost, there is no such thing as a "generic AB-rated" NDA, as is implied by this post. If it does get approval as NDA, it will not be eligible to be automatically substituted for Oxycontin like other generics would be. Second, as an NDA, the abuse-resistance features will **NOT** be compared to **JUST** Oxycontin. It will also be graded against every other oxycodone ER NDA, including Extampza, which has an oral abuse ADF label, unlike Oxycontin.
In summary, the company did not take my advice and submit oxycodone ER as an ANDA. As a result, their drug will need to prove abuse deterrence as good as all other NDA's, which means it will need a successful chewing study. No PEO-based drug like this has ever had a successful chewing study. Supposedly, the study has finally been done, so where are the results of IPCIF's chewing study??? That's a question I've been publicly asking for longer than 4 years now. Looks like we'll have to wait for AdCom #2 to find out the results, which brings us to the third way this post is incorrect. There most definitely will be an AdCom in order to discuss the nasal and chewing HAL studies, which were notably absent at AdCom #1.
If IPCI wanted the advantages of an ANDA application, they should have submitted one. NDA's play by different rules, and those rules are not in their favor for this particular drug.
Intellipharmaceutics' PDUFA 2 months away end of August. Company reapplied and got a 6 month PDUFA date. Company should have reapplied earlier. Second PDUFA is about 2 years after the 1st one. Hopefully, no 2nd CRL for IPCIF. Amazingly, Remoxy got rejected 4 times and is still not approved. Remoxy's first filed back in 2008 and has been working on the drug for over a decade.
It seems Oxycodone ER is basically a generic of Oxycontin. I am guessing FDA will not hold another Advisor Committee meeting since is it so close to being a generic. All IPCIF has to do is show Oxycodone ER is equally as abuse-resistant as Oxycontin to get approved. IPCIF claims Oxycodone ER is bioequivalent with or without food so the drug meets the requirement to be generic AB-rated.
Agreed wimusky, and unfortunately time more than proved everyone who called this disaster 5 years ago right. And their number 1 complaint back then was Dr. Odidiot and the dilutive financiers he kept going back to the broken record well with to keep paying all the salaries involved for the severe lack of progress and results.
And despite all the times back then Odidiot claimed that he knew what he was doing and the growth blueprint he had IPCI following that multiple CFO's pretended was on track, time has more than exposed that he never really had a plan or knew what he was doing...he simply rushed Rexista to a disastrous adcom any other bio CEO in his position knew was destined for failure. And despite all the additional dilution since the failed Rexista adcom he still never got Rexista back in front of another adcom. Heck he never even reached a settlement with Purdue et al despite Purdue's patent protection expiring in 2 months lol.
And 5 years ago now there was very few of us who would've ever believed that IPCI would fail as badly with their entire ANDA and NDA pipelines as they have, to the point of total and complete absurdity...as now instead of even trying to develop and commercialize generic drugs with novel delivery tech systems contained within...Dr. Odidiot has completely stripped their drug pipeline off of their corporate website and is now trying to do the exact same thing with CBD/MJ drugs he failed at doing with generics and NDA's over the past 10 and a half years...and the entire decade plus he's been at it...not once did he cut back salaries or try to cut IPCI's R&D costs.
He just keeps pumping out new fluff and diluting as a failed OTC start up company stuck in a perpetual R&D phase while all 50 IPCI employees and the board of directors involved keep getting paid for delivering a severe lack of any relevant progress or results. And the same thing that's already occurred on IPCI's failed pipeline will simply continue occurring until Odidiot bleeds this stock dry and starts spending all his time in China trying to peddle his wares over there...with the only difference being that the Chinese govt will never let him get away with half the things he got away with here...right down to not bothering to inform the market about all the CRL's IPCI was receiving...which to this day is the number 1 reason so many of us got fooled/blinded into believing his scientist background was a bonus CEO credential...when truth be told it was IPCI's main fatal flaw because a qualified bio CEO would never have purposely hid the many CRL's IPCI was receiving from the market and their shareholders!
Doog- Clearly Odidi has no clue what to do anymore. So he just jumped on the cannabis bandwagon... Like you said it would have been a good call 5 years ago. But Odidi is a copycat. He has no original ideas. He sees someone making some money and decides he will get into that sector. But he moves at a snails pace and the market is gone by the time he gets his approvals...
Who in their right mind will give Odidi money right now? I am convinced that all the recent offerings were short sold in advance. Then the goons covered with the shares they got from the offering. But I don't see that as a possibility now... And who is going to give Odidi another $5M? The answer is nobody in their right mind. He might get lucky and get that money... But he will sell 90% of the company to do it... Once again the shareholders get the shaft...
And who holds all the IPCI shares from the last offering? Over 15M sold and Sabby, Anson, etc. hold pretty much none... So who got stuck with all the shares?
Funny how as numbers just pointed out the ANDA pipeline has been stripped off their website completely while Odidiot starts pumping out more CBD/MJ fluff.
The only part of last weeks IPCI fluff news that the market can 100% count on for accuracy is this final paragraph from the PR lol>>>
There can be no assurance that we will be able to develop cannabis-based products or that any cannabis-based product candidates we develop will ever be successfully commercialized or produce significant revenue for us.
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