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I agree. Hopefully marketing details will come with the announcement. 5-10% market share to start isn't unreasonable, imo.If there product quality starts proving out among the other extended release competitors than we'll slowly garner more of the market. Of course none of us will complain if that's ultra conservative, lol.
As I tried to post yesterday this pr "delay" is just our early access to the Orange book. Yesterdays approvals are probably going out as we speak electronically. The approval list will update this afternoon after the notices go out then the pr will follow.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=120732503
"IPCI doesn't show a partner arrangement on this candidate either. So not sure how/if IPCI might monetize this candidate."
Right, Focalin w/Par is the only partnership we have with a pending partnership deal with Teva but it won't be this product as they have both extended releases on the market alreay. Par also has both strengths in the market, as well.
Would be nice if they could go it alone without much/any dilution.
Mike, I've heard several people who have contacted Mr. Penna all say the same thing. "I'ts in PAR's hands". This says IPCI did the BE retest and handed it over to PAR (as our agent/distributor) for submittal to the FDA. I think we should hear about it relatively soon, imo.
"Still wondering about Focalin as there is no indication Par has completed the BE work. One would think they would have jumped on that given market share gained with the other strengths."
There she blows!!!!!!!!!!!!!! You've got it! Now this is what I've noticed before folks. The new approved listing from the FDA will come out right after lunch tomorrow showing all the 23rd approvals. The question is will we get the pr from IPCI first thing in the am or after close/next day from IPCI. The reason I say that is this approval is electronic so it will be in their inbox prior to the start of day tomorrow but wonder how much after the pr will come. Just a thought in case we don't see the pr in the am.
I saw that Doog. Also look at the very last one #295102 (Secan)filed well after IPCI and approved/tentative last Dec.
It is listed which means an approval is coming but thus far it has no approval date Mike. That could be tomorrow though. I saw a Keppra update from the parent company UCB? earlier this month I wonder if that's what we've been waiting for? Good news anyway.
Stability and abuse liability studies still need to be completed, (Q2) then the data is compiled thereafter and submitted.
Agreed, Doog. The lack of phase 3 testing for Rexista is the biggest thing that has occurred to validate this company to date, before the public, regardless of the present stock price and our history of delays. The rest is just gravy when, not if, it occurs.
Morning Hondo, been watching that as well sitting @ 2.49. Last time it flipped within a few days we had the Rexista news. Wouldn't that be something to get some significant news as a tailwind?
Ah, nice add Sugar, forgot about those. I just wanted to highlight we have more going for this company, on a short term basis, at this particular time, than we ever had to keep interest alive and sustainable.
Well sprot, you are entitled to your opinion obviously. The strength of the stock in light of the market plummeting since the first of the year shouldn't escape your attention that there's more afoot here than a "chance" unexpected good news will be in the annual report and therefore that's the reason for the stock performance, on a technical basis, bucking the biotech slaughter.
The Rexista news we had a month ago was our saving grace to buffer us from returning back to the 1.80 range with the market drop,imo.
I expect our earnings to be right on target especially with the curtain climbers back in school for the full quarter.
Lastly, we just hit 6.5 months since we received our devastating news on the Focalin bio-equivalency retesting which took us from our lofty heights just in time for the end of year tax loss sellers to get out and then back in after their 30 day wash rule ended. Short term I believe that's where the focus is. Investors are aware the company got caught up in a guideline upgrade that didn't stop sales. We could get that news at anytime.
So with all this and the 50 day rising @ 2.17 I believe that's what will be different "this time", imo. I also don't think big money wants to get caught up on the short side of the trade with all of this going for the company and a possible ANDA approval at anytime as well.
Yeah have a good weekend Hondo and everyone else. Hopefully a better than expected or spot-on earnings report awaits us next week.
Whew!, I had to reread it hondo. I thought it said you were trying to make sense of the chart patterns after a 2 martini lunch spread. I'm clear now, lol.
Well maybe the AF for you is Absolutely Free but not Anything Fast
Thanks for the education, Hondo. All my other search engines missed it, lol.
Good call on that yesterday, Doog. Nice move up to shake a few in this range for the interested parties.
There is a provision in section 12 of the Par agreement in the 2013 annual report at the end that addresses the breach of agreement upon a bio-equivalency failure. Par had 5 days to terminate the agreement but they did not. I think it's safe to assume that IPCI did the retesting and now it's in Par's courtyard.
In case people haven't looked at this amended agreement before, Par submitted a Focalin Anda as well (#202842) which would put the date in mid 2013 by my estimates. This may be for the 25/35 mg as either party can submit their own version as part of the renewed agreement. Notice the special section on the 40mg as well.
Good info as to what is documented. There was a payout upon all the Focalin strengths being accepted upon initial review on the bio-equivalency data as well.
Par wants their 10 yr payback.
http://files.shareholder.com/downloads/ABEA-43EQSZ/1343549967x0x726597/9729877C-0DCE-42AD-9AEE-628EA07FEE3E/IPCI_20F_filing_for_SEDAR.pdf
One of the things we've noticed with this company, over the yrs., is that lack of public communication. Perhaps that's part of there frugal nature to save costs whenever they can.
Having said that there is a pattern here you may appreciate. They announce publically the problem areas and address them privately to continue with the positive results. IOW, if they couldn't, shouldn't, wouldn't, etc. which would have changed the original plan of whatever has been previously announced, then it's been assumed it's been taken care of and back on track.
Don't forget 2 of 3 of the tests they didn't have a problem with so it sounds like something minor. Getting 2-3 dozen people together tested roughly over a 3 month period isn't a big deal.
So this pr is roughly 3 yrs. old and the last presentation still has it listed as "in review". I think it's safe to say it's moving along.
It's what I like to hear particularly when there's demand.
Morning Doog, as we know the IBB has been falling off a cliff since the start of the yr. It looks like it just bounced off of it's 200 dma. on the weekly. Nice place to solidify interest in biotech once again. IPCI holding up well considering. Nice blast-off point with a solid floor. Just needs some love.
Hey Trenches, if I can add to Doog's good response. Notice he uses words like "potential and label claims" speculative terms which are appropriate here.
"Best in class" "World class" are a couple of designations based on actual performance by rating agencies. So the hard bragging rights of those terms come over a period of time based on performance with the competition, market share, etc. I don't think that "title" goes to a #1, however, I think that goes to the top 1/3 or something like that. I would anticipate at this juncture Rexista without Podra's would be more in this competitive arena than with it.
Once Rexista with Podra's comes out there will be huge interest/focus from all types of healthcare media, investment groups, etc. giving it the notoriety and press it will deserve particularly if the competition hasn't caught up yet.
"The irony is the picture has gotten better in a fairly short period of time."
Much. The ANDA backlog was constructed to hit large markets and the approval timeframe/backlog was significantly less, designed to fund many different programs buttttttttttttt the rest is history.
Some analysts have us clocked in around .50/share in earnings for 2016. People will debate that but regardless that still is a big difference from yearly losses we've been accustomed to. This is from people who have been covering prior. Kind of a draconian move for the people without vision.
Lol, patience is a virtue that's for sure. All good for all of us soon!
Hey Z, the annual report ought to be coming out in a couple of weeks but I don't anticipate anything new on it especially with the additional Focalin bio-equivalency testing that was unanticipated which they may have needed some funds out of the treasury for.
Keeping their cash levels up for anticipated negotiations is what I think the focus is on now. They may have sold a few shares in the recent Rexista news but we won't see that until 1st qtr results come in. I noticed 24.2M shares O/S in their last presentation so still frugal as usual.
So I would have to go with the Focalin approvals but anything on your list will do
With all due respect, Sugar, Doog and I already have a NDA co-patent on that scientific method called "it's about#^<~C=.. time with extra !@#$%^&* resistant and !@#$%^&* deterrent properties built into it which will expire upon solid news which elevates the share price for good. Your ANDA will not be challenged, however, as we expect the patent to expire soon, lol.
Nice coverage:
TLSR: You said you own two companies in the addiction category. What's the other one?
BC: It's a specialty pharma model called Intellipharmaceutics International Inc. (IPCI:NASDAQ). The company has a tamper-resistant formula for OxyContin (oxycodone), and right now it's going through all the stages to try to get it approved as a generic, but it has some qualities that some of the other tamper-resistant products do not have. This is interesting because it is going to be incredibly difficult to do any studies on. The product is one where you can take 10 of these pills, but you still only get dosed to the level of one pill.
TLSR: I can see why clinical studies would be difficult. You're not going to give human patients 10 pills to see if it works like it's supposed to, are you?
BC: No, you are certainly not. It's hard to do a double-blind study on something like that where you're going to load somebody up with a potentially toxic dose, but I've spoken to analysts who have looked at this, and it could be an amazing application of this technology.
TLSR: Thank you, Bruce, for your insights.
Bruce Campbell is founder and portfolio manager of StoneCastle Investment Management Inc., and he is former portfolio manager for some of the largest investment dealers in Canada and the U.S. Campbell brings more than 22 years of experience to fund management. He is a graduate of the University of Alberta with a bachelor of commerce degree specializing in finance, and he has earned multiple designations in investment management, including the Chartered Alternative Investment Analyst (CAIA) and the Chartered Financial Analyst (CFA) designation, one of the most prestigious designations in the financial industry. Campbell is a past president of the Okanagan CFA society.
http://www.thelifesciencesreport.com/pub/na/look-north-for-value-priced-growth-in-healthcare-stonecastles-bruce-campbell
Ok what "despicable" person would flat out tease us earlier with a 4% gain and then take it all away, lol.
Yep, for sure. An exert from you link:
“Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence,” added Califf. “It’s time we all took a step back to look at what is working and what we need to change to impact this crisis.”
Ummm, perhaps approve our NDA when we submit it, doh!
IPCI getting better and better handling these large market swings. People by and large don't want to be left out when the good stuff hits.
Can't help but feel we'll get Effexor XR, Glucophage XR and Protonix one after the other when the first one gets approval. Six years is more than enough time.
Absolutely! I believe when the Doc embarked on this ANDA program he didn't envision the quagmire embedded in the FDA routing process. The wait is bad enough but then the submission is outdated even before it can get through the process, with safety and abuse concerns in particular. Changes in bio-equivalency standards. Labeling to reflect all these changes. Having to get a NDA owner updated, that have had their products in the market for years, before a generic can proceed in the approval process, (essentially frozen in the system), is another drawback. Concerns are starting to creep up with Lamictal now and it's not at the top of our list. What a mess!
Thanks goodness we had a couple of Focalin strengths "slip by", while we're working the NDA route, showing some progress from both fronts to the shareholder.
It may be all about the "patent" as matteo says but in our circle an extra "i" is needed as the "patient" has been king thus far.
We about to get rewarded for the effort, however. This stock has been under accumulation for awhile now.
Looking at the ANDA approval lists the analytical can see some pertinent activity of late:
87% of the approvals in Dec. were after our 2010 submissions
81% of the approvals in Jan. were after our 2010 submissions
This means more resources available to work the older ones asap. Recent FDA testimony to a Congressional committee still committed to eliminate all backlogs by next year. Unfortunately for us, certain priority criteria has allowed newer submissions to bypass the first come fist served system. Plenty of competition in our older submissions carried a lot of weight I'm sure.
I find the recent work with approvals with the dexmethylphenidate hydrocodone molecule over the last 4-6 months, with many companies, in particular focus.
Mylan and Watson's approvals in Dec is in particular interesting as they were with us in Nov. 2013 with the 15, 30, 40 mg. seeking approval themselves as these were the newer strengths and perhaps their bio-equivalency data was flagged for these strengths as well. If we acted upon our initial notice in June and just did the study upgrade perhaps we would have been with them in Dec. That being said, (2) months behind them, is our time on the cusp of approval near term?
Yep, follow the money! They are patient. Zacks does have a history of helping out the buyers. Perhaps our best indicator you won't find on charts, lol.
CMF has been positive for (3) weeks now. The last time we were positive for (5) weeks prior to the pop out of the 1.80's.
Edit: Can't help but feel that Zacks taking advantage of the IBB still searching for a bottom as well.
It only makes sense, thanks.
I thought the company could get those results quickly submitted (3 months) and then another 3-6 months to get a reply but what do I know. So Feb-May?
This being a 2009 ANDA, we should get the priority treatment as much as possible, imo.
Sprot, I understand your bitterness with the past disappointments with the company and it's easier now to flag them when you're, for the most part, out of the stock. However, nothing fundamental has changed with this company despite delays beyond IPCI's control. I'm sure if the Doc's crystal ball had been working properly he wouldn't have put so much up-front effort into those ANDA's trying to generate revenue as quick as possible.
Having said that, the developmental collaboration agreement between Par and IPCI is still in force regardless of the merger with Endo. Par did not take a 4% equity stake, make milestone payments, cover litigation costs, etc. to just be satisfied with their cut of the (2) Focalin strengths to date and walk away. There would be a breech of the agreement as the distributing partner filer dealing with the FDA. The Doc has stated he would do whatever it takes to meet the new bio-equivalency requirements as owner of the technology and Par will interact with the FDA with the renewed filing.
Farther more, Par has already seen the market share they're enjoying on just the (2) strengths alone. I doubt they would be foolish to loose out on the rest. It is also in Endo's interest to generate revenue from Focalin sales as they don't even have a dexmethylphenidate product on the market.
Absolutely Doog and if the Rexista partnership is just the forefront of a much bigger deal to get the other opioids to market quicker, look out below for a much more up front lucrative deal in the works.
Just for insight, Collegium is into "our" abuse deterrent pipeline with their latest IND hydrocodone submittal.
The Doc is up to the challenge, however, once funds available as Collegium added shares recently to raise $55M.
http://phx.corporate-ir.net/phoenix.zhtml?c=253995&p=irol-newsArticle&ID=2131105
One thing that we know is cleared up is the direction of the partnership offer with the phase 3 trial not needed. So if indeed, in principle, there is an offer on the table, negotiating the hard numbers should be all that is left.
The potential partners concern should be not to take too long trying to get the best deal for themselves, however. Someone else may be looking at the potential increased market share IPCI's technology offers. Competition tends to help get to the end result quicker, though.
Domenic is really cranking up the road shows to get the word out. I like the pr Tuesday that said "by the way, I just booked us one in Florida tomorrow, later". He may even hit a few Motel 6's on the way back home, lol.
The added features comparing our market cap and best-in-class product to competitors is a nice touch showing investors there's more bang for the buck at current prices. Can't help but feel some of that soaked in leading into the afternoon yesterday.
The lack of a phase 3 trial is something that will eventually get notice to the undervalued position of the company and quality of the potential NDA.