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Hey, understand, anything's possible. I just didn't want us to get all hyped up that a locked-up deal is here now when there might be a reasonable explanation for the omission. Having said that they can go right on and pr an agreement anytime that they purposefully took off the presentation. I can take that kind of egg on my face.
We wouldn't know if the FDA had a problem with the IND as IPCI wouldn't pr the communication to us and just address the concern tacking more time on, BUT what is telling is there is a standard 30 day stay which had expired in Sept before IPCI can commence trials if no concerns. The presentation in mid October shows the completion of phase 1 trials for the first time which states (2) things: no safety concerns with the IND submitted and they completed trials in roughly 30 days which means they aren't fooling around and we do what we do best once more and wait on the FDA to review the info.
"They must have a partner understanding which commences upon approval?"
That would be great Hondo if not before but this new entry took
it's place:
"IPCI first to demonstrate bio-equivalency to Oxycontin"
Now he either forgot to re-insert the partnership portion as the last corky dot again, on that page, or just figured it's captured under "key take-aways" and that's sufficient, who knows, but it's still in the presentation at the end.
A partnership announcement tomorrow would work for all of us I'm sure, lol. Either way, it's coming.
Well it must have helped since we're green, lol.
The bio news we received last week really has buffered us. We would have been back in the 1.80's without it, imo
Nice to see the updated comment in today's presentation despite another market blood-bath.
"IPCI first to demonstrate bio-equivalency to Oxycontin"
Although stated, hopefully Domenic stresses they did it without a phase 3 requirement as well as a highly efficient phase 1 covering phase 2 requirements unlike our future competitor (Collegium) who will remain nameless, lol.
They are presently working on their Stability and Abuse Liability Studies prior to submitting their NDA for review. We want that Liability portion to really shine demonstrating the potential lives that can be saved from proper use. This will go a long way to a quicker approval timeline, imo.
"FDA Guidelines define abuse liability as “the likelihood that a drug with psychoactive or central nervous system (CNS) effects will sustain patterns of non-medical self-administration that result in disruptive or undesirable consequences” and the guidelines differentiate between the likelihood/severity of self-administration and the likelihood/severity of undesirable consequences."
As I recall there were a total of 13 patents expiring next year. This was an extension, due to the abuse deterrence modification upgrade they incorporated in 2010, which would have expired the patented molecule originally in 2013. They only gave them a few extra years as the molecule was the same. I don't know what they each were but they all had to do with the original formulation.
The abuse deterrence aspect is what expires in 2025 as I understand it.
Hey Doog,
We should closely monitor this lawsuit as this could have easily been IPCI earlier due to the similarities of Collegium and IPCI. They are getting the dirty work out of the way paving the way for IPCI later on.
The original oxycodone molecule expired in 2013 but Purdue saw the writing on the wall, as well as stacking lawsuits, and came up with the reformulated product in 2010 which only addressed the snorting and injection parts of abuse thus sending the addicts to heroin.
This allowed them the extended patent expiration timeframes expiring next year. If I remember correctly 3 of 4 patent challenges were tossed as stated but regardless Purdue will milk this up to the patent expiration anyway.
The tentative approval for Collegium by the FDA was based on the lawsuit already filed by Purdue so one might assume the NDA filing perhaps was the trigger.
What is extremely important is the FDA utilized an outside committee who voted 23-0 to approve the drug. The FDA isn't bound, or doesn't necessarily follow these recommendations, but often does. Also Collegium has it's own drug delivery platform just like IPCI.
Both companies will have an extreme advantage coming to market as those who don't have their own delivery system will have to adopt Purdue's and that patent expires in 2025
Penna staying busy:
Intellipharmaceutics to Present at the Noble Financial Capital Markets’ 12th Annual Investor Conference
TORONTO, January 19, 2016 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) ("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, today announced that the Company is scheduled to present at the Noble Financial Capital Markets’ 12th Annual Investor Conference on January 20, 2016. The presentation will take place at 9:00 A.M. (EST) at the Club Med, Sandpiper Bay, Florida.
The presentation may be accessed through the Investor Relations' Events and Presentations section on Intellipharmaceutics' website at www.intellipharmaceutics.com.
Time to dust-off my moniker. Congrats to all of us who had the fortitude to be in the stock at the time of this great announcement. You don't get enough credit for your public optimistic stance, Doog.
We needed some positive news after having the rug pulled out from under us on the Focalin XR news and the continuance of the FDA dragging their feet on our 5yr ANDA's. It "only" took the FDA 9.5 months to validate the companies phase 1 findings but saved a lot more time and money should the NDA be accepted mid-year and approved thereafter.
This public announcement will raise the bar on future negotiations with perspective partners already at the negotiating table and test competitive bids from other interested parties especially with the limited players available for the future opoid market, imo.
Yep, let the ANDA revs pay the light bill and research. Cash flow positive will solidify investor confidence while we develop our NDA's
Don't look now but Mylan just received "tentative approval" on their 5, 10, 40mg Focalin XR strengths a couple of days ago, lol.
Even if you knew the number, how would that help you? Sprot couldn't get Domenic, awhile back, to acknowledge any CRL's on any ANDA, to confirm there was communication going on. The mere fact Domenic stated they're looking at least 1 approval this year tells us they cleared the NDA hurdle and are working on getting that 1 ANDA in order to comply with the FDA.
How many amendments will the company have to submit? How much communication will have to take place back and forth before the FDA is satisfied? Each of those could take several months. So it is impossible to nail any time as each ANDA may require different requirements and that's without getting into the competence and consistency of the FDA reviewer.
We have only 3 working days left this month and not a single 1 of those 329 ANDA's I laid out 11 days ago has been approved. They have their 10 "first time generics" done once again as previous months. That means a whooping 78% of the approvals so far this month have been with ANDA's submitted after our 3 oldest.
Those other 329 are in flux, caught up by the FDA requirement changes made after they were submitted. It sucks but that's why we're fighting to get through the quagmire.
Hey Doog, had some time to look at this today. I like what I've found on the ANDA front. I believe all 3 of our oldest ANDA's have been held up but reviewed at least once. Whether it's all primarily NDA labeling conformance that still needs to filter down to completion or some other small documentation needs in tandem is anyone's guess. Since Domenic has mentioned that they anticipate 1 ANDA approval before yrs. end then obviously he knows the communication aspects of what is being addressed and I doubt it's been in IPCI's court.
The last 2 months of approvals has been somewhat telling:
From ANDA #201593 to #202161 there were 568 ANDA's dated 2-18-10 to 8-31-10. Our 3 oldest are in that mix. Out of those 568 there were 137 approvals since. Prior to that however, 2010 was the largest rejection rate of ANDA's submitted @18%. So 18% of 568 is 102. So total accounted for is now 239 leaving 329 as of 7-31-15. That still sounds a lot but here's the kicker.
The last 2 months of data is telling:
July had 42 approvals with 27 of them after #202161 which is 64%.
June had 56 approvals with 35 of them after #202161 which is 62.5%
However both months saw "first time generic" approval at 10 each as they're the priority. These are the 09.... numbering system used in 2009. Once these are all gone they'll jump those extra people into the 200...'s since there aren't any 100...'s.
Adding in these extra 10 per month now takes the percentages to 88% and 80% respectively. The 12-20% suggests that these have been more than likely been "pawed over" at least once not waiting for review.
I believe the approval Domenic is suggesting is Effexor as the Pfizer labeling last December filtered down to a company who received approval in May who happened to submit their ANDA in the same timeframe as IPCI in 2010.
All speculation, of course, but it does hold promise things are finally coming around and we aren't still buried somewhere in a stack waiting to surface.
I looked at these well over a yr ago and correlated them with other ANDA's. They're issued in numerical order. Those ANDA's are companies submissions between 2-18-10 and 8-31-10 and correlate with 3 of our oldest ANDA's. Our 4th oldest ANDA will be about the 202240 mark which was submitted 9-30-10. Make sense?
Things are picking up a bit. Notice the list below correlates with the companies you listed. The focus is/has been to get "first time generics" to market. As you review the monthly approvals on the FDA website concentrate on how fewer and fewer ANDA numbers below 201593 are becoming, indicating a higher percentage that one of our pending 4 are coming up for review. We are looking for roughly numbers between 201593 and 202161. If they concentrate just on those (which there are many that have been approved already) it would take about a yr at their current approval rate if none have been approved at all so we are a lot closer. It's not all that simple, as we know, but it gives you an idea, imo.
The Office of Generic Drugs (OGD) fully approved 47 ANDAs and Tentatively Approved 12 ANDAs for a total of 59 approval actions. While the number of full approvals falls below last month’s GDUFA high of 57, nevertheless, it represents an above average month for approvals for OGD.
The number of receipts in July was 40, and, thus, OGD managed to keep ahead of the receipts and will have the net effect of reduction of the backlog. At a net decrease of 19 ANDA/month the backlog that is hovering around 4000 will be around for a long time. Approval numbers really need pick up steam if OGD hopes to eliminate the backlog of pending applications.
With the new GDUFA FY 2016 fees just announced and an increase of 29% in the ANDA fee, we wonder if we will see a big push to get applications submitted before the new fees go into effect on October 1, 2015. Or will ANDA applicants hold off on submitting their ANDA even with the higher fees, in order to take advantage of the Cohort year 4 metrics that require OGD to review 75% of ANDA submitted in cohort year 4 in 15 months? It will be interesting to see if the differential in the higher fee or the 15% increased chance of being reviewed in a 15 month timeframe will drive industry decisions.
On a more positive note, I noticed that the FDA Monthly Approval site already lists 10 full ANDA approvals and 1 tentative approval with only 3 business days (August3-5) so far this month. This certainly represents a good start for this month.
Nine First Time Generic Approvals in July
By Bob Pollock | August 12, 2015 | FDA, Generics, Regulatory Affairs | ? 4 |
Of the 47 ANDAs approved in July 2015, there were 9 first-time approved generic products. These represent the first time that the generic product was made available in the marketplace and demonstrates the Office of Generic Drug’s (OGD) commitment to getting first generics into the marketplace at the first available date.
The list of first-time ANDA approvals for July includes the following:
ANDA No Generic Drug Name Generic Manufacturer Brand Name AP Date
1 78-027 ALMOTRIPTAN MALATE TABLETS, 6.25 MG (BASE) 12.5 MG (BASE) TEVA PHARMACEUTICALS USA AXERT TABLETS 7/7/15
2 203431 TRAVOPROST OPTHALMIC SOLUTION USP (IONIC BUFFERED SOLUTION) 0.004% APOTEX INC. TRAVATAN Z 7/10/15
3 90-848 OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP, 0.2% BARR LABORATORIES, INC. PATADAY OPHTHALMIC SOLUTION 7/13/15
4 90-811 BIVALIRUDIN FOR INJECTION, 250 MG/VIAL (SINGLE USE) HOSPIRA, INC. ANGIOMAX INJECTION 7/14/15
5 90-816 BAVALIRUDIN FOR INJECTION, 250 MG/VIAL; PACKAGED IN ADD-VANTAGE VIA HOSPIRA, INC. ANGIOMAX INJECTION 7/14/15
6 200624 REPAGLINIDE AND METFORMIN HYDROCHLORIDE TABLETS, 1 MG/500 MG 2 MG/500 MG LUPIN LIMITED PRANDIMET TABLETS 7/15/15
7 200904 LINEZOLID INJECTION, 200 MG/100 ML 600 MG/300 ML SANDOZ, INC. ZYVOX INJECTION 7/16/15
8 205473 ETHACRYNATE SODIUM FOR INJECTION USP, 50 MG/VIAL PAR STERILE PRODUCTS LLC SODIUM EDECRIN 7/29/15
9 204152 OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS (OTC) 20.6 MG (20 MG BASE) PERRIGO R&D COMPANY PRILOSEC OTC DELAYED-RELEASE TABLETS, 20 MG 7/30/15
So far in FY 2015, OGD has approved 71 first-time generic ANDAs accounting for about 19% of the 373 ANDAs they approved through July 2015. The 19% is down a bit from FY 2013 when about 25% of the ANDAs OGD approved were first-time generics (see previous post here).
OGD has indicated that first-time generics are a priority for review; however, many of the ANDA numbers associated with the July first-time approvals represent ANDAs submitted prior to 2009 when the numbering system changed to a consecutive system of number assignments for NDAs and ANDAs (the 200-000 series of numbers). So the numbers list in the 90-000 series was submitted prior to that and the 78-000 series number in the list was actually submitted to FDA in 2005. Now, it is possible that there might have been patent issues or exclusivity blocking approval, but, needless to say, all first approvals may not have been expedited due to certain circumstances beyond the scope of this bloggers specific knowledge.
http://www.lachmanconsultants.com/2015/08/office-of-generic-drugs-july-numbers-are-in/
Common opioids used for spinal cord injury related pain are:
•Tramadol
•Oxycodone
•Morphine
•Fentanyl
•Codeine
•Methadone
•Buprenorphine
http://www.apparelyzed.com/pain-medications.html
Meanwhile, while we wait, the game plan continues with these .20 swings to load the boat as cheap and for as long as possible.
Stability isn't so bad.
"We believe Par will launch the 5mg strength imminently, as the 180-day first-filer exclusivity recently ended,".............
That's why you have to scrutinize these analysts as Brean has it right based on previously released information.
Maxim stating exclusivity ends at the end of the month missed the boat on this one.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=115373043
While we are all waiting for the 5mg Focalin XR approval news to hit it is a given that we all realize the cog in the FDA wheel turns slowly.
Teva's experience has shown how to get approvals done quickly with the 15mg. They hit the road running the day after our exclusivity expired because they proactively sent an amendment on March 27th (roughly 7 wks early) to make sure they would be ready by May 19th. Obviously they didn't have the updated bio-equivalency issue to contend with which could have potentially set them back.
In our situation, we now have (2) data points to track which "might" lead to a trend. The timeframe from the updated requirements to the reversal was (3) weeks. Am I suggesting the same timeframe to approval? Perhaps.
Looking back on the Maxim analysis (which didn't make sense) there may be a hint of validity to his August approval timeframe, not to his exclusivity expiring at the end of the month comment, which I believe is an error, but to that (3) week period I mentioned which would be July 29th to August 3rd.
Just a thought. I think we'll get an update by Monday am. Obviously my wish would be an approval by then.
Yeah the 5mg "should" make them cash flow positive unless R/D increases but that's a good expense to see. We also should get a cash infusion from Par upon approval if I'm not mistaken.
I keep checking the FDA website after lunch. Yesterdays approvals are now posted. I have this vision of catching our approval before the company announcement. I know "good luck with that", but........
Like you, how hard is it to wake the guy up at the next desk and say "approve it already", lol.
Ok Who Dey, you caught me, lol. When the FDA rescinded their recent decision on the 5mg my focus shift went from "eventually" to "very soon" on the approval front which can allow some optimism I would think. It's been almost 2 yrs since our last approval and I've been here almost 4 yrs so seeing some of our optimism renewed is sort of well, new
Serious accumulation continues. Approval is in the air!!!!!!!!
Why did Rexista receive fast-track status?, hmmmmmmmm let's see.
"Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need."........
"Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy."
Yeah that's got Rexista's name all over it. Check out the rest of the link, good stuff!!!!!!!!!
http://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
Thanks Hondo. That 400 page pdf draft had a lot of info mostly dealing with new drug development. We'll have to see the Senate version later this yr.
For what it's worth, here is the testimony from the CDER director at the FDA to the subcommittee over a yr. ago. It appears most if not all her comments/recommendations are incorporated in the bill.
Note what I highlighted. If I was a Congressman on that committee I think I would say "Ya Think?", lol.
To her defense though, she is limited by the protocol in place and resources she has. Very few knobs to turn.
Master Protocols and Clinical Trial Networks
One of the most serious limiting factors in drug development is the time and expenses required to design and conduct the Phase 3 clinical trials needed to demonstrate drug safety and effectiveness. As the President’s Council of Advisors on Science and Technology (PCAST) observed in their 2012 report on drug innovation:
Clinical trials constitute the largest single component of the R&D budget of the biopharmaceutical industry, at approximately $31.3 billion, representing nearly 40 percent of the R&D budget of major companies. Unfortunately, there is broad agreement that our current clinical trials system is inefficient. Currently, each clinical trial to test a new drug candidate is typically organized de novo, requiring substantial effort, cost, and time. . . . .Navigating all of these requirements is challenging even for large pharmaceutical companies, and can be daunting for small biotechnology firms. Even in the best cases, the complexities add considerable time to trials—subtracting time from a successful drug’s eventual time on the market without competition.4
Drug development need not necessarily be done in this way. There are often much better alternatives to reinventing the wheel every time a new clinical trial begins, including, where appropriate, the development of clinical trial networks and master protocols. The recently initiated Lung Cancer Master Protocol (Lung-MAP) is an excellent example of a new, less-costly paradigm for developing drugs, one that benefits both drug companies and patients. A master protocol creates a single clinical trial infrastructure that can test many drugs at the same time. Development of such a protocol requires close coordination with CDER reviewers, scientists in academia, NIH, and possibly other organizations, and the protocols themselves typically go through a peer review process. In the case of Lung-MAP, patients are assigned to one of five different drugs being simultaneously tested, based in part on their genetic profiles and their likelihood of responding to the study drug, and additional drugs can be added, while others are dropped, over time. The goal is to increase efficiencies through the use of a common biomarker screening platform, a common algorithm for assigning patients to multiple protocols ongoing concurrently, and the potential for sharing control patients across protocols for a given biomarker profile, all of which are possible because of the infrastructure established for the master protocol. FDA is highly supportive of master protocols.
http://www.fda.gov/NewsEvents/Testimony/ucm404647.htm
Just kidding mopar. I have their greatest hits cd (Vault).
Great day with IPCI!
Big money continually buying at these levels Wrinkles.
Definitely something in the works.
Ah yes, that's right, the Def Leopard concert. Definitely giving away his age, lol.
Yeah that Doog even he's not here he spends his free time on the Nasdaq trading floor filling buy orders.
Gotta luv it, lol.
"The surprise reversal by the FDA has screwed up someone's timetable IMO."
Nice way of putting it Hondo.
The link mopar provided showed a March report issued in April. If there's a current report perhaps it's by subscription only, I suppose.
Not that I'm anxious to read what those clowns have to say.
Yes, previously they would drive it back down when it hit this level but I guess the strategy is to try to limit the upside while covering until big new hits and can't stop it.
I haven't seen an updated Zachs sell report as posted here but they've done that before to help clients cover, imo.
Doesn't look like that's helping drive it down thus far if that's the case. The 5mg approval is in focus now. They won't chance driving it back down again I wouldn't think.
Are you saying he should stay away more often, lol.
Don't tell him I said that.
The tide is turning here. We are trading on what is perceived as coming up not what has been. Positions are being made/enhanced. The stock isn't being hammered back down like it was. A different breath of fresh air we haven't felt in awhile to be sure especially after an earnings miss.
Bring on the news!
Go IPCI, a rare "pump" from me.
Just to be clear after reading today's post, IPCI has never submitted an ANDA for Coreg, an ANDA for Oleptro was submitted months ago but never pr'ed and we should get an update this qtr on the Pregbalin status going forward.
If you visited the FDA website earlier today (or now for that matter) you'll notice the approvals put out from Friday the 10th that were sitting for 3 days.
They slipped up however and put out an approval for the 13th (today) for AstraZeneca (AZN) this am as well, at the same time. Had I any spare cash I would have bought the stock as the news wire didn't pick it up until after the company released it 3 hrs. after close. There was a spike up at the close as the news "leaked" out hrs after I spotted it.
Nothing to do with us just trying to capture the mess that surrounds the rubber stamp of approval that we're waiting on but can't understand nor appreciate the quagmire associated with this gov't bureaucracy even when we know it should be passed through quicker.
Hopefully we'll hear something soon. Tomorrow they might put out todays rubber stamped approval list, etc.
"Let's hope we hear from the FDA this afternoon!"
"Final approval for the 5 mg strength (10% of the market) should come soon (August), as the exclusivity period of the first filer expires at the end of the month."
Either he's a little messed up or Teva didn't actually launch the 5mg in November as we believe.
If he replaces the "5" with a "10" I think he would be a little closer to our understanding but, whatever, we'll see the inevitable eventually.
This where our new DORA employee might come handy. When our Focalin XR exclusivity expired Teva's approval came 2 days later. So staying on top of the FDA apparently is key, imo.
Doog, if you remember they didn't with Glucophage either.
It's been in development for many yrs.
Hey Doog, bummer on the Q's slight miss but the yr/yr blowout comparison was definitely expected.
Do you smell a Penna strategy here? He puts out the blasé earnings report AFTER he engages the investment community on the Focalin XR reversal news. This allows the stock to recover to it's Rexista fast track level and also keeps the stock from being potentially hammered further because the focus is now on the inevitable approval of the 5mg soon not the slight earnings miss. The reversal news was actually a blessing in disguise because we wouldn't have had that hint and focus would have reverberated back to the earnings report while still questioning the 5mg approval status. In other words, we avoided another buying opportunity once again and the shorts aren't playing with the good news around the bend.
Hey it's your money. The shorts aren't playing no more after the reversal news. The approval is just a formality. I think earnings will be better due to the currency deficit affecting a better than expected outcome. I know we've had a long wait with setbacks but that's coming to a close real soon!
We are back to where we were before the bogus news but it's up to you.