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For the times they are a-changin'. Let the buyer beware.
https://seekingalpha.com/news/3529916-key-events-next-week-healthcare?utm_medium=email&utm_source=seeking_alpha#email_link
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.
BOOOOOOOOOOOOOOOOOOOOOOOOOOOM ..ticker is IPCIF
RALLYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYY
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
Thanks Jack will do some due on it, hope your 2019 has been awesome glty!
If you guys want to get your money back do some research on DARE
Samsa… Can you provide any input into this settlement of 1.6 million for the class action?
With their expenses they are breathing on fumes now.
So MNK finally terminated Seroquel, let's see if Tris develops into anything meaningful
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?
Agreed bro! Not gonna last much longer b4 the plug gets pulled and Odidiot galivants off to china to peddle his wares to a brand new audience lol
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
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
Glad we have the combined $4 Billion markets with SunGen LineUp.
Nasrat diversifying.
Elite will pick up Purdue’s bones and clean up the carcass.
ELTP
yep, bad news for IPCI, and ELTP
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.
FDA did this, but IPCI completely blew everything up to this point.
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 announced 2nd Quarter 2019 results:
https://www.intellipharmaceutics.com/news-media/press-releases/detail/206/intellipharmaceutics-announces-second-quarter-2019-results
Yep toxic funding for this penny stock as Dr. Odidiot continues waving the white flag & throwing in the towel
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.
They need more money to make it to PDUFA.
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.
Camargo says there are AB Rated 505(b)(2) NDAs:
https://camargopharma.com/resources/blog/ab-rated-505b2s
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.
Dangerously incorrect.
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.
ANDA Pipeline page restored on Intellipharmaceutics' website. ANDA page was probably omitted by accident. Page is backup after a couple of weeks.
Intellipharmaceutics' ANDA Pipeline.
https://www.intellipharmaceutics.com/product-pipeline/anda-candidates
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>>>
Hard to believe this bio company reached such a point of total and complete absurdity that they're resorting to hiding their ugly list of failures from the public domain, while simultaneously pumping out CBD/MJ sector fluff that will never amount to anything like their badly failed and exposed ANDA and NDA pipelines.
10 and a half years since IPCI went public, and the only thing Odidiot ever partially succeeded at was the 180 days of exclusivity on 2 strengths of FocalinXR way way back at the end of November 2013.
Beyond that mini-success over 5 and a half years ago, every single other thing Odidiot blew $10's of millions of dollars in dilutive funding on was a total and complete across the board failure.
Numbers- Odidi and company have certainly failed on monetizing their ANDA pipeline. They should just sell it off. I am guessing these items have been removed from the website as they are trying to reinvent themselves as a cannabis company and removed the evidence of past failure. Odidi and company have no market vision. They just copy what is already being done. And their copy attempts are not executed fast enough to actually profit. Heaven knows what they are working on in the cannabis realm. But it is already a crowded space. And as far as I know, most cannabis benefits are anecdotal at best. The only FDA approved drug in this space is for seizures. For once I would like to see Odidi at the front of something innovative. But so far, just me too stuff. The three I's... First come the Innovators, then the Imitators and then the Idiots... I would have to say Odidi falls between Imitator and Idiot.
IPCI's Ranexa NOT among 4 FDA Approvals 5/28/2019. FDA did give final approval to the tentatively approved applications on 5/28/2019 to: 1) Actavis, 2) Ajanta, 3) Cipla, and 4) SunPharma. Lupin was the first to file and launched 3 months earlier. All patents for the drug expired 5/27/2019, so Lupin only got 90 days exclusivity, instead of 180 days.
IPCI's website is currently missing ANDA pipeline page. There is only IPCI's homepage with OxyER and Regabatin listed and no page dedicated to the pipeline. I find no link or webpage to an ANDA pipeline.
Doog- Pretty crazy that IPCI holds onto those ANDAs that they cannot commercialize. I guess someone will have a use for them at some point. They certainly are not gaining monetary value for shareholders. But they do present Odidi with many options once the company files for bankruptcy.
All the talk is tariffs. I hope people in the US understand that this 25% will be paid by US citizens. Yes, China may lose business because of it but US citizens pay the 25%... Sounds like a new tax to me... Money out of our pocket to the US government... Sure sounds like a tax to me...
Lastly, people are already instituting hiring freezes, etc. I am guessing these tariffs will benefit the select few that know in advance of the major news. Like when to get in and out of the market. No doubt this all comes down to how a select few make some money while others suffer the consequences of poorly chosen leaders with greedy personal agendas.
The moment Odidiot got slammed and embarrassed by the Rexista adcom panel his actions since then prove that he threw in the towel here and has zero ability or desire to create a shred of value right Samsa.
So I totally agree that wimusky has Odidiots entire China backup plan figured out, and he's just gonna continue paying the 50+ salaries via dilution for as long as the market will absorb said dilution right!
It's just too bad that Odidiot failed so miserably at both his ANDA and NDA pipelines despite blowing through well over +$150M in dilution over the past 10 years. Had he been successful on a single drug then we could've at least launched a class action to regain some of our lost investment funds.
And the worst part is that I blame the FDA as much as Odidiot for even scheduling the doomed fateful Rexista adcom with only the IV properties identified by the FDA as supposedly up for FDA approval discussion! Had the FDA not purposely mislead all us IPCI investors into foolishly believing that the 4 IV properties were really all that was up for panel discussion on that fateful day, then every single 1 of us would've been forced to objectively view that fateful adcom day much harder than we ended up doing...but since it was the f-tards at the FDA themselves who scheduled the 4 IV topics up for agenda discussion that day, the FDA ended up being the main culprits responsible in fooling us IPCI investors into believing the AdCom panel was supposedly only going to be discussing the IV qualities the FDA themselves put on the adcom agenda...and we all learned that definitely was NOT the case to all of our collective chagrin.
And the saddest part about it is, that even if we all immediately blamed the FDA for their faulty Rexista AdCom IV agenda, there probably wasn't anything we could've collectively done about it back in July 2017 anyways, which is why the FDA is allowed to get away with fooling the investment community when they're just as responsible for perpetuating faulty misinformation as a lot of biotech PubCo's are.
Hell, the main reason the FDA probably had the faulty Rexista agenda in the 1st place was because they were Trump appointees who had no biz working at the FDA anyways like the majority of Trumps appointees throughout the govt sector hahaha
Let the era of floorless toxic death spiral financing commence right wimusky. Sick how far off the cliff the Odidiot allows his careening IPCI 18 wheeler to keep falling without a single care in the world when it comes to creating even a tiny semblance of shareholder value whatsoever.
I just wish all of us IPCI investors knew how truly ill prepared for Rexista adcom they were back in July 2017 so we could've all bailed instead of foolishly believing in this pathetic CEO and technology platform.
In IPCI's entire 10 year existence the Odidiot only got 1 thing right, he somehow succeeded in getting a 180 day exclusivity period on 2 strengths of FocalinXR!
But beyond that, the entire ANDA and NDA pipelines are 1 of the most colossal failures ever witnessed on any bio stock out there. And for sure Odidiot's China backup plan is still where this is eventually headed after he bleeds the market completely dry in a few more months on the OTC with as many toxic funders as he can find willing to sell this down to no bid and dilute to the tune of billions of shares.
There was opportunity here in the 1st 5 years but the exact moment the FDA came along and dragged IPCI into the court battle they were having with the manufacturers of Concerta this company was doomed and never recovered!
Pristiq full approval today. Time to sell off the ANDA approvals for operating cash. No reason for shareholders to continue to take the hit to pay the Odidi salary slush fund. One thing is for certain, that moron clutches those ANDAs very tightly for some reason?
Will be interesting to see how they come up with money to fund operations after they run out of cash in about 4-8 weeks. Time to make a deal, make some cuts at the executive level and sell off some assets... Who in their right mind will actually give Odidi money this round? Last offering was a total scam and Odidi got burned. All that money from that offering was generated via short selling in advance. Then when it came time to price offering, Odidi's "friends" pulled the rug out from underneath him. So it will be interesting to watch what happens. My guess it is nothing short of a pathetic attempt by garage shop management to raise funds. My guess is he gets about $4M but needs to sell 75% of the company or more. And every one of those shares will be attached to a warrant that in the event it goes up, the low life financiers have their ass covered.
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 an order was issued on April 24, 2019 setting the trial date for the Company's ongoing Purdue litigation case, case number 17-392 in the District of Delaware. The trial is scheduled to begin on November 12, 2019 and a decision is expected by March 2, 2020. The 30-month stay date is now March 2, 2020.
Even- I read it the same way.
The time to make a deal would be now but I have no confidence Odidi can get this job done. He sure has never done this in the past.
The time would be now to sell off the ANDAs and approvals but Odidi has no clue on how to run a business. It seems like he is holding onto these like they are his baby. They are not generating revenue and it appears there is no plan in place to monetize these, so sell them off...
So how toxic will this offering be? I think you got it right that he will need to raise $4-5M. But at what PPS. My guess is 10 cents but it could be as low as 5 cents or as high as 20 cents. But once again, Odidi is terrible at business so probably sub 10 cents.
Interesting fact that shows Odidi won't invest his money in an equity stake in IPCI that is at risk for dilution:
1. The Odidi loan originated in 2013. A loan for $1M @ 12% has collected roughly $720K in interest since inception in 2013. So that investment is still worth $1.72M. A gain of 72%.
2. A shareholder who invested $1M in IPCI in 2013 as an equity stake now holds roughly 40,000 shares at a total value of between $8-10K. A loss of over 99%...
If i read the last report correctly, they are down to about 1 million in cash, which they burn through each month in expenses. They have a new PDUFA date in late August, but that is 4 months and $4 million away in spending. They have to raise more cash by the end of May at the latest, and until that happens I doubt anyone is going to buy.
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