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List of wishes (in this precise order from today to 31 december 2016)
1. approval of residual focalin strenghts
2. Podras patent approval news release
3. Rexista NDA Filing
4. Partnership Agreement with a big name
5. 1 ANDA approval
6. Partnership Agreement for Regabatin
These "magic" chain of events will cause institutionals to jump in and at least three waves of big short squeeze and 2 short re-building which would make the share price insane.
My dream
GLTA
Numbers,
"PODRAS is to reduce accidental overdose of intact tablets and really not an abuse deterrent. Is accidental overdose of oxycodone a major problem? I think someone with no opioid exposure can still overdose on one higher dose pill. "
I think that the "accidental" you stressed out even in other posts should also be combined with "deliberate"
"A basis for the request was that Rexista™ Oxycodone XR has the potential to address an unmet medical need, namely the prevention, deterrence or reduction of the abuse of oxycodone HCl extended release solid oral dosage forms involving the deliberate or inadvertent oral ingestion of more intact pills or tablets than prescribed to achieve a feeling of euphoria. This is a very common and serious form of drug abuse."
From what I understand, with Rexista+Podras you can prevent the abuse via manipulation of almost any kind AND via simple ingestion of increasing number of pills (which is where current products are lacking, according to Califf interview)...so to me should not be a minor devlopment.
JMHO
Angelo, Samsa,
I'm as technically prepared as both of you (even if in different grounds),
but I think that your two different reasonings about PODRAS could come to a solution (forgive if I'm wrong on this one):
from the company press release:
"About Rexista™ Oxycodone XR incorporating PODRAS™
The Company's Rexista™ Oxycodone XR product candidate has been further enhanced with its proprietary PODRAS™ delivery technology intended to reduce the likelihood of oral abuse when more pills than prescribed are swallowed intact. Preclinical studies of Rexista™ Oxycodone XR suggest that if more tablets than prescribed are deliberately or inadvertently swallowed, the amount of drug active released over 24 hours may be substantially less than expected. However, if the prescribed number of pills is swallowed, the drug release should be as expected."
Angelo I tend to believe that preclinical studies have already been conducted; if you look at the wording in bold they are clearly referring to the PODRAS technology.
If that's true I would stick with Samsa reasoning about the supplemental NDA, which explains the delay in Rexista filing as linked to PODRAS patent, most likely than not included in the Agreement.
Comments more than welcome
Interesting read, but honestly I don't find how you came up the Califf possibly putting barkes on Rexista. He's making a much wider reasoning.
The buprenorphine transdermal patch i called Butrans and it's Purdue's.
I think that will be in their own interest to make the Agreement public; I'm not sure if they have some obligations when it comes to SEC-filings to release a minimun required info.
Also much will probably depend on the partner; if it is a "small" name (like Shionigi for Egalet) than it could be easier to maintain a certain level of secrecy; if it is Purdue or Pfizer, than the news will hit all the major media...with subsequent digging to have more details.
Communication could also be the like: we received an updfront payment of X, a next payment of X upon final approval, royalties...., and a total package up to XX for PODRAS, etc...
Shares will move in proportion (exponential) to the X values
Another point you often stressed (being right): Royalties payments based on sales (not earnings)
"Acura receives from the Company, a stepped royalty at percentage rates ranging from mid-single digits to double-digits on net sales during a calendar year based on OXAYDO net sales during such year. In any calendar year in which net sales exceed a specified threshold, Acura will receive a double digit royalty on all OXAYDO net sales in that year."
Angelo,
I'm reading SEC filings of the IPCI competitors.
Among various interesting aspetcs I have found under the last Egalet 10Q a very good example of Licensing Agreement (which was by the way terminated in 2015).
Considering the early stage of products development when it was signed (2013) the structure reinforces what you several times proposed on this board. If we make a comparison with IPCI current stage of process....
Take a look
"Under the terms of the Shionogi Agreement, the Company received an upfront payment of $10.0 million in 2013 and payment of $10.0 million in April 2015 upon submission of an Investigational New Drug (“IND”) application by Shionogi. The Company was eligible to receive regulatory milestone payments under the agreement as follows:
(i) an additional $50.0 million upon successful achievement of specified regulatory milestones for the first licensed product
candidate;
(ii) up to $42.5 million upon successful achievement of specified regulatory milestones for a defined combination product candidate;
(iii) up to $25.0 million upon successful achievement of specified regulatory milestones for a second product candidate (other than the defined combination product candidate);
and (iv) up to $12.5 million upon successful achievement of specified regulatory milestones for further product candidates.
In addition, the Company was eligible to receive up to an aggregate of $185.0 million based on successful achievement of specified net sales thresholds of licensed products.
That's exatcly what TonyPro's Group has been making since the last couple of years.
I think the company is well aware and from the tone of Odidi's interview posted some days back I have the feeling they are trying to have them caught in between ...hopefully squeezing them when they are pushing the price down with their gaming
Wimusky,
just wanted to make others on this board aware of what kind of strategy Sprot is pursuing.
Sprot,
you are just confirming to belong to the group of people following the other ipci forum and website.
The same group which asked Odidi more than once to step down,
the same Group who put downside pressure when there was new share issuance
The same group who strongly would like us to sell so that you can grab our shares cheaper and try to get control of the company.
Considering the market cap I myself know a couple of person which could take control (from a financial standpoint) of ipci.
Going back to the prediction gift that you have: could you tell us where the price will be in december 2016 ?
Samsa,
great logic tree kind summary !
Last week I wrote that it would have been suicidal to go at the conf with no news....go and check it.
Then sell.
Sell your long
Or increase your Short
Just sell
Just do it
4Q2016 = sept-oct-nov
Patent approval will be the trigger
Hei Sprot,
"others (and People with influence) can make or breakdown a Co"
your comment sounds like those of TonyPro;
either you are a just a shorter starting to get nervous
OR
you just want the share price to collapse in order to buy tons of shares and get rich afterwards.
You are the only one here with the kind of expressions "wait and see" "I'm telling you" and the like...
and everybody here remembers you saying more than once that it would have been @ 1.50 on the 1st of september.
C'mon Sprot
Samsa, Angelo,
I think you're right in saying no major news will be given out of surprise during the presentation; I'm not sure whether or not thay can update saying NDA filing was completed (sent).
Partnership to be dependent on patent final approval, which should be anyday now (patent approval I mean).
therefore, even if frustration could hit us in case of no news released before-during-immediately after the conf, I think that we could have the next 3 months with a combination of catalyst that - if all goes positively - will make the Vegas party closing.
Hi Doog,
do you know which company is acting as Market Maker on the NASDAQ for IPCI shares ?
Angelo, great idea the 10$ Vegas party.
Would be nice to exchange emails and phone numbers; is it allowed by IH policies ?
Sprot,
you predicted 1.50 share price as of 1st of september, due to the delay in filing.
So you were right on the delay, but wrong on the share price.
Now you are comparing an up-more-than-10%-day and 600k on volume with a down day 1% with 20K on volume...you gotta be kidding.
Please, if you are honest you should stop making your "Wait and see" statements.
Others on this board are all briging their views, critics and reasoning...you are the only one shooting downward target price from week to week (Always remembering to everybody that you are going to profit if the price goes up)
Confused
I was looking at Yesterday volume/price action.
First there was a big order was when (around) the update on the patent office web site.
Then we had again two volume spikes with some decent orders.
My idea is that these but orders where from someone very deeply involved in the deal; in fact there was no news and I don't believe the article on the Street alone would have caused whis movement.
By the way, timing of the article was good (lucky) and this could help us as well in gaining more exposure at the right timing.
Doog, Mopar,
incredible job on the patent application process understanding and catching the timing of final step.
Tek,
I think Angelo is right, buy when something is sure is not the kind of biotech investing.
There a number of stocks which made incredible price jumps once some catalyst became clear.
To me the reasons for not having institutionals at the moment are:
- very low float (call it investment liquidity for a fund terminolgy)
- lack of company communication
- some management errors
Once some catalyst will start to materialize institutions will start to enter, causing a re-pricing of the sotck veeeery rapidly.
I have 3yrs time horizon from now, which will amount to a total of 6yrs investment and my target is the "tenfold" of my initial investment....and I believe that 6 yrs would be more than worthy
from last Q results press release:
"As of July 12, 2016, our cash balance was $3.4 million. We currently expect to satisfy our operating cash requirements through November 2016 with cash on hand."
I agree on all points.
One step a time.
Let's go IPCI !
The way I see it 2 are the possibilities:
1- They already filed (which I would desume from options granting, usually linked to some company milestone achievement)and they want to announce it at the conference, to get max audience
2- they are about to file, delay due to a number of possible reasons, but they better file by the week end or communicate something the soonest possible.
For what concerns partnership, I think it will be signed once PODRAS patent is granted and if I'm right this is very positive, because would mean that Rexista II is in someway included in the contract (= big partnership)
There is always the possibility that they are delaying the filing, not communicating it before the conf, releasing a new possible deadline during the conference.....but that would be suicidal from an investor relations point of view.
The only reason I'm giving this last scenario a lower probability is the presence of Della Penna
ELTP -9% - Elite Pharmaceuticals says warning letter received on Aug. 26 relates to certain observations that FDA believes were inadequately addressed by co’s response to a form issued by FDA from a recent facility inspection.
Letter says Elite’s Standard Operating Procedures do not adequately address how to monitor and receive adverse drug experiences
FDA also believes co. failed to investigate, evaluate and timely report adverse drug experiences
Co. currently addressing deficiencies cited in letter; intends to work closely with FDA to resolve any outstanding issues
Reply was to Doog...
Samsa,
I like your timeline.
I also think (JMO) that they are going to have something concrete for the presentation at the next conference in 2 weeks.
Wouldn't be wise to go there and saying nothing new except for some delays.
And they announced their presence there some days go...therefore either they are pretty sure of they will have by that date or they are making a bad error of communication.
Based on your timeline, which I found very plausible, I would expect (note the wording) share price to reach currently unthinkable levels (note the wording again)
Burocracy is the MAIN risk for IPCI.
I still don't believe it when I see Effexor XR, Glucophage XR and Protonix ANDAs allnow aged more than 6 years
when I read the FDA recently stated that their mission is to clear the backlog I'm not sure if laughing or crying.
Hope the patent office is a little less lazy (corrupt ??)
The only consolation is that a good number of catalysts are now getting even more close in time and close to each other...perfect combination for a dreamed price run !
Good luck to all of us longs.
Shorters and weak hands already in action !
Even if at this point seems unlikely, I think that the best timing for the filing announcement would be this evening or tomorrow before opening.
@suisse, while you wait for the picnic @ 1.50 I think you won't be with us for the Gran Gala Dinner...(just kidding)
Ok, fair enough. I respect your opinion but I have a different way of looking at it.
I believe someone here is putting too much enphasis on the filing date:
1- IPCI deosn't have an FDA deadline for filing Rexista, but it's a selfimposed indication
2- filing per se will not have much impact on pricing (viceversa filing delay will cause some selling by those people that, like yourself, think that the filing date is of Paramount importance)
3- to me Partnership is the word for the company's historical change; entity of the change depending on several different apsects of contract agreement
4- IPCI has some pending catalysts other than Rexista filing
As some of you stated, with a delayed filing we could go back to 1.50.
So I consider that risk acceptable, because I believe point 3 and 4 above could trigger a price jump that you'll never catch up with if you stay out of the stock.
That's the biotech game....risk (going back to 1.50) vs reward (3x or 4x pricing re-rating)...and nobody never knows the right timing...NEVER.
it's a matter of risk/reward perspective
JMHO
So Sprot,
just to be clear about your feeling: according to you IPCI is not filing Rexista NDA by end of August, but what do you think ?
1 - they are never filing
2 - they are fililng in 2 or 3 months from now
3 - they are filing with just some days of delay
And, if you are so kind to answer me, right now:
- are you long IPCI ?
- do you still believe in the company as investment case (time horizon ?) ?
I'm with you Angelo
300 pieces @ 2.25 in pre-market; is it a joke ?
Hi Angelo,
I drop a couple of lines to the author..saw your msg as well.
There was some one else's too.
Samsa,
I think I can say that nobody on this board is forecasting IPCI to a 1bln company by the end of the year.
What I've read many times is that we could have a 1bln company in 3 to 5 yrs.
at current shares count it would mean 40$ per share
Suppose we will have 40mln shares and the price would 25$
That's absolutely fine (or better: amazing) for me either way.
You are right to point out some of the issues we will have down the road (by the way I think the biggest is FDA itself), but those of us who are suggesting 1bln or more mkt cap for future IPCI are at the same time speaking about an horizon of at least 3 yrs.
Celator was valued (mkt cap) by the market 85Mln usd at the beginning of march 2016:
Jazz Pharma paid 1.5Bln !! in cash in July ...4months later.
Shares went from 1.8usd to 30.25 during that period.
This is a perfect example of how much difficult a biotech company valuation can be.
Samsa,
I took some time to look at SUPN (which I'm sure you know much better than me).
I think it we have many differences with IPCI, but I wouldn't use it as a warning as you put in the board, but the other way around, showing how much value the mkt is giving to a single product, Trokendi
That's what I would highlight (JMHO obviously)
1- Trokendi (which you reported as example) was approved in 2013 and is having impressive sales growth "During the first quarter of 2016, prescriptions for Trokendi were up 56%" . "The company has guided to Net product sales in the range of $200 million to $210 million this year with operating income in the $32 million to $37 million or approximately 55 to 65 cents a share of profit. The company earned just 28 cents a share in FY2015. The consensus forecast has Supernus earning over $1.40 a share on over $270 million in revenue in FY2017."
2 - when approved the company's stock was @ 5; now it's 22
3 - SUPN, which has other 6 licensed products with negligible revenue, has a mkt cap of 1,1Bln USD (almost entirely due to to Trokendi)
I think everybody here would sign for IPCI having a 1bln mkt cap in 3 yrs from Rexista approval, let's say in 2020
Amigo,
I'm perfectly aware of the costs; you are right on that.
But then unless you make the assumption that IPCI will be going to market other products and developments on in its own (which I found extremely unlikely and I hope it won't happen),
then each drug is going to be partnered.
It's correct to consider other product costs, as well as consider relative revenue.
Costs are coming before revenue, for sure, but when partnering the logic of the game changes a little bit.
And we are not considering the pending ANDAs...which right now seem to be dead.
I don't want to pump, I'm not that kind.
But when you look at market partnership and transactions concerning biotechs you understand that my very rough example using a p/e of 20 is by definition ultraconservative (= you can likewise say that of those 20mln just 10 are bottom line and use a much bigger p/e multiple, to incorporate future costs).
The fact is that a lot of the biotechs have incredible costs, much higher mkt cap than IPCI and NO earnings. So it is very difficult to estimate the correct company value just based on usual financial metrics/methods.
I want to make my idea very clear: a lot of the future will depend on the kind of Agreement signed (Rexista only, Rexista+ RexistaII, the entire technology Platform) and on the kind of Partner (PFE, Teva, etc).
Once we will have the deal, then it will be relatively easy to understand the value given to the partnership/company.....and IF the technolgy is sound, it will become clear to everybody.
Disclaimer: I'm always happy to confront my ideas, to learn from Others due diligence and to consider new perspectives.