evenkeel
5 years ago
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.
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The FDA strikes again.
evenkeel
5 years ago
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.
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This is the worst type of financing, because it incentivizes them to get the lowest share price so they get more.
doogdilinger
5 years ago
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:)
WeeZuhl
5 years ago
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.
WeeZuhl
5 years ago
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
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.
numbersarefun
5 years ago
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
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.
wimuskyfisherman
5 years ago
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.
WeeZuhl
5 years ago
Dangerously incorrect.
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.
doogdilinger
5 years ago
Intellipharmaceutics Announces Receipt of Cannabis Drug License from Health Canada
May 30, 2019
"Our receipt of a Cannabis Drug License from Health Canada demonstrates Intellipharmaceutics' commitment to the research and development of a pipeline of pharmaceutical CBD-based products, but also shows why we believe we are uniquely positioned to bring cannabinoid based, prescription drugs to the Canadian and global markets," commented Intellipharmaceutics' CEO, Dr. Isa Odidi.
The sheer lengths Dr. Odidiot will now go to keep diluting to pay all the IPCI salaries involved prove how shameless his IPCI charade has become.
And now that he's failed at launching a single successful ANDA or NDA candidate, he's moving full steam into CBD/MJ pumping despite knowing for 5 full years now that he was single-handedly responsible for IPCI's failed ANDA and NDA pipelines.
Had any of us known he was gonna become desperate enough to start pumping out MJ/CBD news, we would've all suggested that he started pumping out the MJ/CBD fluff 5 full years ago where/when this company's once potential for growth hadn't yet been completely destroyed. And does anyone else find it beyond hilarious how shortly after these 2 posts last September Odidiot abruptly decided that IPCI was gonna move into CBD/MJ hahahaha>>>
doogdilinger
Thursday, 09/20/18 08:17:34 AM
Re: swe77 post# 36709
0
Post # of 38591
Another bio bites the dust. MJ's a much better sector for the foreseeable next several years imo
TRENDmendous
Thursday, 09/20/18 10:28:06 AM
Re: None
0
Post # of 38591
I saw this mentioned on another board so figured I would send Intellipharmaceutics the question: Even though they NEVER respond to me! Worth planting the thought in their minds.
Have or are you looking into a controlled/extended release Tetrahydrocannabinol (THC)? Cannabis is becoming the "next best thing" in the market currently! Cannabidiol (CBD) may be another option to look into.
Just a Press Release (PR) stating that you are looking into these two cannabis constituent's would skyrocket the share price!
numbersarefun
5 years ago
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.
doogdilinger
6 years ago
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
evenkeel
6 years ago
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.