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In the aggregate that means that about 10 percent of the time overall – at least using meetings since and including 2011 through 2016 FDA decides ultimately on a different course than was recommended by its advisers. So next time someone asks the question, you have an answer.
I fully agree with you fred - although not counting on it.
Draft Points to Consider
1.Has the Applicant demonstrated that oxycodone extended-release tablets have properties that can be expected to deter abuse by the IV route of administration?
2.Are there sufficient data to support inclusion of language regarding abuse-deterrent properties in the product label for the IV route of administration?
3.Does the committee have concerns regarding of the safety of exposure to the excipients in this product if administered by the IV route for the purpose of abuse.
4.Should oxycodone extended-release tablets be approved?
The suspense is killing me fabius.
Do tell... what A is equal to what B ???
This will be sold at $2.50 - $3. I wish more but realistically not possible
I would advise that the Odidi's show a vote of confidence by announcing they are buying 250,000 shares of IPCI on the open market.
I would imagine they are good for $250K... if not... sell the yellow Lamborghini to raise it.
Of course... they would not be able to if there are negotiations going on that would materially affect IPCI's share price.
Any talk of delisting at this time is asinine.
Stock price would need to be under $1.00 for 30 days before a warning is sent out - and then 180 days period is granted to meet compliance - upon those 180 days an extension can be applied for, and in most cases granted - so at minimum it's 13 months from now, if everything goes wrong.
On the other hand... if everything goes right... IPCI could be trading above $10.00 in 13 months... and MANY HERE KNOW THAT!
Angelo- I believe 2018 they will do $4.0-6.0M total on Focalin, 2019 $3.6-5.4M, 2020 $3.2-5.0M. After that revenue will roughly erode at 10% per year.
muskyfisherman... what do you think will be IPCI's TOTAL royalty revenue on Focalin XR for the remainder of the contract life???
Picked up 5K more to add to the 260K - would buy more but have nothing left to sell.
Will I be the hero in my life... or will I forever be it's victim???
If I had a Million Dollars I would buy 1 million shares of IPCI
But if they dilute down here rather than sacrifice a small part of the pipeline... they will break my heart and perhaps my spirit.
Sell Focalin's royalty rights for $10 million... or even $5 million if they have to... sell it for 70% or even 50% of estimated royalty payments going forward 10 years... just don't dilute... weather the storm... just don't dilute... sign a disadvantaged partnership... just don't dilute.
JUST DON'T DILUTE.
to reiterate:
Seroquel XR total market is now $775 million - for every 1% market share that MNK captures it equals $7.75 million to MNK and IPCI yearly.
I believe IPCI's royalty on Seroquel XR to be 40% but will use 30% to be conservative... so every 1% market share equals $2.3 million to IPCI.
I believe there are presently 6 companies selling Seroquel XR... so if MNK gets it's share of the market... it could/should capture 16% market share... which would/could translate into $36.8 million per year to IPCI.
Sounds like fairy land to most here... but lets say they get 20% royalties... then their yearly royalty will be ~ $24 million... based on 16% market share.
OK... let's knock down the market penetration to 8% instead of 16% - and at 20% royalty payment it's still $12 million a year.
I don't know how far backward you want me to bend to show the potential here... but this is not wishful thinking... it is fact... it is on the market NOW!!!
The unknown here is how efficiently and aggressively will MNK be... what % share of the market will they capture... and how soon.
I have no idea how marketing generics works... but I believe it's more like a commodity and if say Walgreen or CVS has ongoing relationship with MNK then they may even be required to purchase from them... would love to hear from someone in the know how this works.
But even at 20% royalty... IPCI will receive $1.5 million per 1% of market share - my personal belief is they will receive a minimum 30% and likely a 40% royalty payment.
Ohhh... and Pristiq which is already partnered with MNK and may be approved any day now... also has the same economics.
The runway has been made longer... but I still believe IPCI will eventually take off.
I'm in full agreement with your perception... and, didn't the FDA lady (liaison?) say something like... well make believe... or... just assume that those safety studies (oral, nasal) have already been submitted.
It seemed strange but it seemed to me that she implied that the FDA was well aware of the oral and nasal test issue and was interested only in their opinion regarding the intra-venous route of abuse.
Factoring is the sale of receivables, whereas invoice discounting ("assignment of accounts receivable" in American accounting) is a borrowing that involves the use of the accounts receivable assets as collateral for the loan.
I sent these 2 Well reasoned opinions over to Della Penna.
Hopefully they give it due consideration.
p.s. I'm in full agreement with the possible well reasoned solutions expressed here.
grill4thrills
Wednesday, 08/02/17 02:41:52 PM
Re: vikinggames post# 29068
Post # of 29088
Hey Vik, if Rexista studies are inexpensive and they feel they can penny pinch their way by on Focalin/Seroquel revenue and use just a little ATM, we probably won’t hear anything at all as they have been doing just that for months I believe.
IMHO it would be downright silly to do an offering here (not impossible, but silly). I say this simply based on the mathematics, whereas say they needed $5M to do complete required Rexista studies and maintain a sufficient cash balance for operations. They would probably have to sell 7M+ shares in order to raise just $5M at these levels after lowering the offer price to generate buyer interest, fees, etc. That’s roughly a 20-25% dilution for just $5M cash…
An alternative may be where they can give a partner say an extra 10% of Rexista profits for the upfront payment of $ 5-10M to help IPCI cross the finish line, which is chump change for big pharma and a good deal for someone to get in this space. I don’t know what those numbers would be, so move them anyway you want, but it would be in the best interest of the company & shareholder value to give up a little more in a partnership agreement than dilute at these prices (ie give up 10% of profits on 1 drug than dilute the company 20+%). It’s very straightforward, so I’m hoping a CFO understands this!
To be short here is simply betting that there is no partner at the table to help with cash concerns, and there is no further development on the ANDA front, which is unfortunately very plausible.
While the adcom surely made the outlook of Rexista look bleak, they were at least consistent voicing the need for safety studies, so if they can complete them and they are favorable… who knows! My best guess is the FDA will delay the PDUFA data if they are close on these studies rather than issue a CRL on Sept 26th. I’m not going to place a bet on that however, I’m just looking at the generic safety net, recognizing that the FDA is making strides on the ANDA front the last few months (average of 69 approvals per month the last 6 months vs just 51 approvals per month the 6 months prior).
To cover all options, let say the sell the rights to Focalin to PAR… let’s just round IPCI revenues to $5M, if PAR we’re to give just $ 30M for those rights, it’s merely a 6X earnings multiple for them since there is no added cost to PAR (which is beyond a great deal btw), and that better be enough cash to operate until more products are commercialized! Just saying… IPCI is undervalued, but unfortunately it is too easy for investors to see the risks at play as well. GLTY
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fred198484
Wednesday, 08/02/17 03:04:34 PM
Re: vikinggames post# 29068
Post # of 29088
The chances of an offering have to be low given the price of the stock. But they have to be high given the lack of cash. For IPCI, however, no cash is the norm and they seem to know how to get by. With revenues now flowing in due to Seroquel and Focalin sales, management likely feel things are better than they have ever been.
My best guess is there will not be any offerings until the share price is much higher. It could get much higher based on a possible partnership deal on Regbatin which the company has said it is looking to accomplish, a partnership deal with Rexista (I don't think the negative ADCOM results will prevent this since the panel so clearly lost its way and all knowledgeable parties know the drug is the best option for the patients) or new generics are soon approved/partnered (if not partnered already).
But if any of these things happen and the share price rebounds, I certainly expect a share offering. But it would have to recover a lot - I would think to at least $4 -$5 per share before any offering would be pursued. I could easily see how a Regbatin partnership alone could instantly change the whole complexion of the company in the eyes of investors and push the stock to the $4 - $5 range. Rexista's potential is impressive but Regbatin is even bigger.
I don't see them partnering PODRAS.
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Agreed, with the wolves in sheep's clothing and buzzards circling, definitely looks like time to add a few shares at these sale prices...
12 months ended January 2017 for Lyrica® (pregabalin capsules) were approximately $4.2 billion (TRx MBS Dollars).
Btw, i think FDA could surprise us, cause adcom was totally offtopic.
Angelo, give them a call to illustrate it...I believe they really need some help
The worst thing they could do right now is dilute down here to finish Rexista trials.
Going forward, they basically have 3 or perhaps 4 possible revenue streams.
Rexista, Regabatin, XR Generics, and possibly PODRAS outlicensing.
If they dilute down here to advance Rexista on their own, they would be cutting any future revenues on their complete pipeline in half to raise perhaps $30 million.
On the other hand... if they partner Rexista at say 1/2 of what they would expected to get if approved - let's say $5 to $10 million up front rather than the ~ $20 to $30 million, and 15% royalties as opposed to the 30% to 40% one might expect to get from an approved drug, + partner picks up all future costs of trials and legal fees... then they cut in half ONLY the Rexista revenue stream... all future revenues from regabatin and XR Generics would remain intact as before this fiasco.
It would be a win-win situation
IPCI gives up half of the potential Rexista revenues to salvage full revenues on the Regabatin and XR Generics... as opposed to cutting their total future revenues in half. ------- WIN
Partner would utilize the $15M to $25M up front payment, saved by partnering now, to bring Rexista through approval... and they would then reap an additional 15% of an approximate $200 to $300 million revenue stream in the near future. ------ WIN
Fully agree with your assessment fred.
Seemed like a bunch of children not understanding their homework assignment and playing follow the leader.
The data on the Rexista Viscosity factor as compared to OxyContin was extremely impressive - you practically can't get Rexista in a syringe.
The only relevant conversation I heard was that there is perhaps a 30 second window where Rexista is injectable... and if injected during that window and it clogs up the vein(s)... what will happen.
My guess possibly a stroke probably kill you but how long before it's common knowledge that you don't inject Rexista or it kills you... so would it not in fact then be even a greater deterrent???
It would take a miracle at this point in time for the FDA to over-rule the panels no vote...but that possibility definitely exists...
Today's panel left so much to ponder.
So Rexista is far less viscous (8X less) than OxyContin which practically means you can't even get it into a syringe... but there is a small window of time that it's same as OxyContin and as injectable... as Oxycontin... but if you inject it then and it gums up in your vein... it could kill you???
Now we don't want to kill anyone... but if that should happen wouldn't it become common knowledge and DETER use.
You think the druggies would all be on the internet sharing photos of their "blue noses" saying look at me... I snorted some Rexista, BUT... not share... hey man... stay away from that shit because it will kill you.
Maybe I'm in denial... but I think that either approve Rexista or take OxyContin off the market.
19-4 was the vote...and the 1 panel member so far that gave her reason for YES...said she voted YES because Rexista clearly does meet the labeling standards for IV abuse deterrence!
They may as well add PODRAS for a phase III
I am devastated.
The only one on this board that turned out to be right is the "weasel"
HERE IS WEAZEL - #7
Folks - this is what OBSESSIVE COMPULSIVE DISORDER looks like.
Boy - it seems like they'll let anyone talk and some are simply people invested in other companies and have an interest in Rexista not being approved - #8 is a stackle-bum - seems he's had a liquid lunch.
Having listened to some of the negative comments I think they will actually strengthen the resolve to approve.
Despicable - Are you getting live Video Feed or audio only... and, was there a charge to get that?
To me today it's very stressful
Thanks Angelo, the concept of preventing the pills from dissolving when too many are taken is scientifically possible. Odidi pulls this off, it's an amazing invention.
This is interesting it uses the same concept of some of the cancer drug that uses a linker that carries the drug through blood circulation and only release in the tumor area when acidic lvl increases naturally around and inside the tumor. In this case, when too many drug was taken it changes the condition so that the drug don't release. Sort of backwards of the same concept. Enclose the drug in something that could identify the condition for release or in this case change the condition to prevent drug release. Fascinating stuff.
I can place my bet at 3:30 today or 2:00 tomorrow .... what difference does it make ..... speculating either way.
When I first read the patent a couple of years ago "I thought" I understood it... although I can't say for sure I understand it... what I do understand will get you closer to understanding it... understand???
So you start out with the original Rexista pill, and apply a coating to it which will require a certain acidic level to dissolve it... what is generally the acidic level of a human stomach.
You then coat that same pill with an alkaline coating - now the alkaline coating would somewhat neutralize the acid in the stomach, but not enough to keep the acid from eating through the coating that is "safeguarding" the hydrocodone... however... should several pills be ingested at the same time, the abundant dissolved alkaline would be enough to neutralize the acid in the stomach and make it incapable to dissolve the coating that is encapsulating the hydrocodone.
Or something like that.
It would seem to me that anyone can disarm the PODRAS technology by simply drinking a shot of vinegar... but I think PODRAS is primarily aimed at "accidental" overdosing.
Would certainly protect a child that thought he/she found a hoard of "good and plenty"
Again... I believe that's how it works... and does really nothing to prevent abuse... but works miracles at preventing accidental deaths.
Would like to hear from anyone if they have a better understanding of the technology.
I had assumed you had assumed... but there's less emotional noise when it's known for sure... thanxs
the stock will not trade tomorrow
SA article just out... "IntelliPharmaCeutics International - Very Low Downside And Huge Upside"
Philipe Mause
The best part is that in less than 48 hours from now we'll have our Rexista AdCom panel vote results in:)
if you recall IPCI took a lot longer to file than we expected - I hope it was because they were in constant touch with the FDA and crossing all the t's and not because they couldn't agree on what was needed to file.
Also, seems the FDA wanted IPCI to enter the market with Rexista... and... would they have accepted the application if it was missing something???... those 60 days are for the FDA to go through the application and decide if all the pieces are there... and it seems they said yea, everything we need is here.
But I'm really troubled and don't understand this comment that IPCI and the FDA have "philosophical differences"??? WHAT??? I don't really think the FDA gives a crap about IPCI's philosophy... was this really a statement from Della Penna as to what's going on???... a philosophical difference???
WOW - can't believe they took the "blue dye" BS argument over to the FDA comment board.
Hope somebody can help me understand why are they having an adcomm if the FDA has put a 30 month hold on a final decision due to the lawsuit and how does it effect the PDUFA date?
The committees will be asked to discuss the overall risk-benefit profile of the product, and whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling.