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I don't know, grill4thrills...I see a total of ~180 lots (covering 18,000 total shares) of open puts across all 4 of the expiration dates (thru October). Certainly not enough to hedge a long position of 60-100k shares. And have you looked at the spreads? Seems way too expensive to try to play put options as a hedge on a long position.
I think their game is more of a pump-and-dump scheme.
But, without a screenshot of trades (yes, those brokerage account numbers can be erased before posting a screenshot), sport's credibility here is zero. For all we know, he will make $250 on 67 shares if IPCI goes to 5.50.
"Anyway, when IT hits 5,5 i'll Be Happy too :)"
That will make 2 of us (many of us here).
But, if you'll be happy if it hits $5.50, why the posts that predict/hope for $1.50?
Trying to figure out your game!
250000/(5.5-1.8).
"If IT Goes to 5,5 overnight i'll Make 250k LOL."
"Make" implies that it's a PROFIT. So, you do understand you have to subtract the cost basis for your shares, right??
Oh, I understand your math now...you now are saying you got your shares for free?? Wow...
I'll just stay away from investing advice from you, if that's okay with you?
I know...I'll go long AND short the same number of shares...that way, I'll make money whether it goes up or down!! LOL
Genius...why didn't I think of this before??
Sounds like he has 67,000 shares? But he wants it to go to 1.50??
Agreed, Dood...I'd love to get edicated on how this is possible. LOL!!
From SEDI today (Canadian Insider stock transactions):
Madhani, Bahadur (director) purchased 1,000 shares at C$2.47 today, and now holds 7,507 shares.
--------------------
A token gesture, but at least insiders feel we are at bargain basement.
Post of the day yesterday, Sugarplum:
I also got a different answer. Based on my DD all is well. That doesn't change the fact that the FDA holds investors and companies fates but that is nothing new. FDA has never been in a hurry about anything except when they told IPCI if BE worked out no need for Rexista p3 and priority given to Rexista2.
XR:
I quickly reviewed the filing.
Does it look like the Odidis' salaries were cut last year? I thought they were getting $750k each in 2014, and now it looks like about $400k each in 2015.
Thanks!
From IntelliPharma (via Twitter):
IntelliPharma ?@IPCIPharma · 4m4 minutes ago
http://buff.ly/1UmaMOI Opioid Abuse, Drug Pricing Raised at NIH Budget Hearing $IPCI
NIH discusses opioid abuse issues:
- Insurance companies should cover abuse-deterrent opioids nationally
- Opioid prescribing should be for severe pain
The other takeaway from this article, is this is NOT just a problem in the U.S. It is a worldwide problem. From the article
These are some of the more shocking international statistics on drug overdosing:
• Globally, there were an estimated 183,000 drug-related deaths in 2012, most of which were attributed to opioid overdose.
• In 2012, the number of overdoses in the United Kingdom surpassed road accident deaths.
• In Canada, between 1991 and 2010, there was a 242 percent increase in fatal opioid overdoses.
• Nearly four Australians die every day from a drug overdose. Like America and the UK, drug overdoses in Australia eclipse road deaths.
• It’s estimated that from 2000 to 2010, over 70,000 people died from drug overdoses in the countries that make up the European Union.
If PODRAS is proven effective and sees wide uptake by pharmaceuticals, the market for this platform is astounding.
Angelo:
I certainly don't consider myself in the league of researchers with you and the others you list, but I'll take a quick stab.
Starting point IMO is what drugs are most associated with overdoses. The following article seems very thorough:
http://www.12keysrehab.com/blog/most-common-drugs-people-overdose-on/
Key takeaways:
Most common overdoses caused by:
• Prescription pain relievers (responsible for a large number of unintentional overdoses every year.)
• Sedatives and antidepressants: (Antidepressant drugs are much more widely prescribed than pain killers. They are also more readily available. Sedatives are a commonly prescribed class of drugs, too.)
• OTC drugs: (Benadryl and cough syrups are sometimes used to achieve a cheap high).
• Heroin, Methamphetamines (stimulant), Cocaine (stimulant), Drug combinations
Looking at the list above, in addition to opioids and sedatives (sleeping pills) that you mention, the other class of prescription drug where IPCI/PODRAS will be useful is the Antidepressants, which are very widely prescribed.
As to the size of each of these markets (sedatives, antidepressants, etc), this will require a more in-depth look...have to do that some other time!
How long does it take for a patent to get approved once it's been published?
maybeesornot posted that the PODRAS patent was published on January 28, 2016.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=120403391
2/8/16:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=120399218
Just saw this posted by someone on Twitter:
Jessica Merrill
?@Jessicaemerrill Just talked to Purdue CEO Mark Timney at BIO CEO, who says 2016 is the year for transformational M&A.
Here's hoping IPCI technology is deemed "Transformational" :)
ADDENDUM:
And then there was this tweet by Luke Timmerman:
Luke Timmerman ?@ldtimmerman · 3h3 hours ago
Mark Timney of Purdue Pharma pushing to raise profile of private co, says he's looking to buy a platform, something transformative #BIOCEO16
Pfizer spent $328M in 2015 advertising for Lyrica (Pregabalin):
http://www.statnews.com/2016/03/09/drug-industry-advertising/?s_campaign=stat:rss
This is the 2nd most-advertised drug, after Humira.
Obviously, quite a large market for Lyrica.
IPCI is developing Regabatin XR, an extended release formulation of Pregabalin.
Feels like games to me, when tavoo and sprot tag-team their negative messages right before larger sales begin.
Absolutely, sugarplum!
It's all about risk/reward. The current stock price on IPCI favors being long, IMO.
The cash balance is low, but for the detractors to state DEFINITIVELY that there will be "serious" or "massive" dilution is disingenuous.
Unlike many companies I know, IPCI has several avenues to raise cash. And as Doog states, they have been very frugal in their management of cash over the past several years.
sprot:
How do you know whether or not, at the time of releasing the year-end results, IPCI was within a few weeks of receiving a large payment from PAR/HANNA?
Just wondering if you have access to insider information that we don't.
Or that the CEO will make another loan on reasonable terms to the company?
Or we are on the verge of signing a partnerships on one of our NDAs/ANDAs, with upfront payments included?
Or...
From twitter (If you're on twitter, @IPCIPharma is worth a follow):
---------------------------------
IntelliPharma ?@IPCIPharma · 52m52 minutes ago
http://buff.ly/21HCSVW New FDA Chief Cites Promise of Harder-to-Abuse Pain Drugs $IPCI
--------------------------------
Key highlights:
By MATTHEW PERRONE, AP Health Writer
WASHINGTON (AP) — The Food and Drug Administration's new commissioner is pledging to fully back efforts to develop harder-to-abuse painkillers...
Accepting NDA filing of Rexista 1 would be a good start!
Califf has already pledged to add stronger warning labels to the most-commonly prescribed opioids, and to consult more with outside advisers. On Tuesday he highlighted the potential of new painkillers designed to discourage abuse. For instance, the latest version of OxyContin is harder to crush for snorting. When dissolved it turns into a thick jelly that is difficult to inject.
Again, Rexista...
"But the promise that we are on a path toward products that are effective in preventing abuse both by patients and non-patients is real. And the agency intends to fully support efforts to advance this technology," he said.
Accepting Bio-Equivalent Rexista without a phase 3 will be proof to me that Califf means what he says.
But public speakers warned that overstating the benefits of abuse-resistant opioids could create false assurances in doctors. To date, it's not clear the new formulations actually translate into fewer overdoses or deaths. And most can still be abused when simply swallowed.
"I am not convinced that we can engineer our way out of this epidemic, and I would caution against over-relying on abuse deterrent formulations to do so," said Dr. Caleb Alexander of Johns Hopkins University.
I don't think Califf, Alexander or the mainstream media have heard of Rexista 2 (PODDRAS) yet. Which is a good sign. Market cap of IPCI will steadily increase once Rexista/PODDRAS is in the mainstream media, as it works its way towards approval.
Among other steps, the FDA is requiring additional studies from painkiller manufacturers to assess the long-term safety and effectiveness of long-acting opioids for chronic pain. Most were approved based on studies lasting three months or less.
This may become an issue, if the FDA starts requiring REMS studies. A post-marketing REMS study would be manageable, but a pre-marketing REMS study would cause delays in approval.
----------------
Copyright 2016 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
Great stuff, dtstx!
Like you, I think we are close to unlocking the larger ANDA drugs.
And, hopefully close on other Focalin dosages.
Thanks Sugarplum.
Tgifbaybay:
You have to go to sedi (Canadian website for insider trades):
https://www.sedi.ca/sedi/SVTReportsAccessController?menukey=15.03.00&locale=en_CA&gx_session=0
Select "Insider transaction detail" and enter Intellipharma and a date range (May->Dec 2015?), and you'll see the purchases by Della Penna.
EDIT: SEDI is a bit cumbersome to use!
CFO's open market purchases (173,000 shares) are far more important to me than how many shares anyone on this board owns.
The 3rd a follow-up comments by Doog with Domenic (#12947) RE BIG things will happen in 2016 and really likes opportunity in Regabatin in addition to Rexista :
---------------------------
Also Domenic was pumped about the fact that he put his money where his mouth is by purchasing 100K shares on the open market and isn't upset in the least that he could've purchased them lower on the heels of the FDA's final flip-flop decision...mainly because he envisions BIG things on IPCI's horizon between now and the end of calendar year next year [2016] ...to say nothing of the years that follow.
He also made mention of the fact that he didn't leave his 2 lofty TEVA positions for any other reason than that he felt IPCI represented an incredible opportunity that he wanted to be a part of.
He also said that TEVA will be announcing which ANDA they struck the deal with IPCI on as soon as the FDA approves that particular ANDA & that IPCI is still planning on announcing other licensing agreement partners as the FDA begins handing down ANDA approvals on the 6 other ANDA's still stuck in the FDA's backlog.
1 final note...Domenic is just as pumped about Regabatin as he is Rexista. He thinks the market is also grossly under-estimating the coming impact Regabatin will carry and misjudging how long it's going to take for that NDA to be FDA approved cheers!
The 2nd from Doog in August RE: a conversation with Domenic (#12944) RE: Rexista :
I was able to verify with Domenic that CONCERTA is in fact considered a sister ADHD generic to FocalinXR and the author of the FDA law blog was spot on in all his thoughts presented in the blog in the link of the post I'm responding to.
So in a nutshell...the FDA after a couple of flip-flop decisions has decided to make IPCI's pending FocalinXR strengths(that were previously tentatively approved according to old bioequivalence standards) meet the FDA's newly imposed bioequivalence standards for generic ADHD drugs...mainly due to the fact that other companies out there have been manufacturing inferior generic ADHD drugs.
And therefore IPCI got caught in the quagmire of the FDA's newly imposed bioequivalence standards through no fault of their own...but now it's simply better for them to go ahead and submit bioequivalence on their 40mg FocalinXR(which does in fact take 60 days from the time they start) than it is for PAR and them to bother with any further back and forth with the FDA.
Domenic further advised that by Q3 results in October IPCI would be providing a timeline update on when 40mg Focalin bioequivalence expects to be submitted.
Domenic says that the market continues to completely under-estimate and overlook the significance of the 2 FDA Rexista decisions of a few weeks back and said that their ongoing Rexista progress alone is so much more impactful than any of their still pending ANDA's that when the street does begin to take notice on Rexista progress...none of us will care about the last unforeseen small hurdle the FDA unexpectedly threw in their path on the 2 delayed focalin strengths.
So the way I see it is this...the single biggest impactful driver right now is ongoing progress on Rexista...IPCI's negotiating with potential global partners...a partner should most likely be announced b4 they submit Rexista bioequivalence...which will then mean whatever partner they end up selecting has built in milestone payments into the contract such as...pymt on bioequivalence submission...Pymt on the FDA advising that Rexista bioequivalence is acceptable...pymt on IPCI submitting their official Rexista NDA to the FDA...pymt on the FDA granting them their Rexista PDUFA date...and pymt on FDA Rexista approval!
Still say that if all goes according to expected timelines...we will get FDA approval on Rexista sometime in the back half of next year...and when that day arrives we'll be looking for a minimum $200M per year in Rexista rev's alone...making all 7 of IPCI's pending FDA ANDA approvals just extra gravy for the real coming meat on their best in class NDA's choo-choo;)
I've been catching up on last year's posts. 3 have stuck out to me from the post-FDA flip flop.
1st from dtstx (#12867) in August RE: Effexor getting close in the queue:
----------------------------------------------
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.
Nice call, smitter! Not as many shares available to buy here, and a lot of shorts trying to cover?
I bought into IPCI over 2 years ago under $2 but sold out at 4.25 on the Focalin run-up. I plan to stay around much longer this time around...I see a lot more action happening over the next year or 2.
I'll take 5-10%...that would be great!
This is where our high-profile CFO can use his connections to close a creative financing. Perhaps a mixed financing of debt/shares to a large bank (or Teva?), backed by the Focalin/Keppra sales revenues?
Enough to close on the real estate, scale up manufacturing, and hire a small sales team.
Exciting times ahead, especially considering that this is one of the smaller ANDA approvals!
Doog:
Thanks for all you do on this board, and especially for this listing of all of IPCI's ANDA submissions and facts about them.
You should definitely sticky note this to the top of this IPCI board. I have a feeling we will be referring to your list often this year!
dtstx:
"Would be nice if they could go it alone without much/any dilution."
Looks like they have a decision here, as to whether they want to partner or hire their own marketing/sales reps.
IMO, if they partner, the return wouldn't be significant. And the Keppra market is too small with too many generic participants to start a large marketing/sales team.
But it might be an opportunity to dip their toes into this area...perhaps hire a VP of marketing/sales and a small sales team in anticipation of downstream approvals in larger markets?
dtstx, Doog:
Thanks for the detailed replies.
Can't wait to see this evolve over the next several months.
Doog:
I've seen you mention this "potential best-in-class designation" a few times.
Is this an FDA designation? Or an industry trade group designation? Or "self-anointed"?
The reason I ask: if it is an FDA or industry trade group designation, this should translate into premium pricing for IPCI's generic drugs OR greater market share. Either of these will be very beneficial for a better partnership and/or downstream profits.
If it is "self-anointed", then it comes down to who among the generic competitors has a better sales force.
Thanks! And glty.
(this might be my last post today, so I may have to resume this conversation tomorrow).
"I wonder what ability there is to possibly scrape off the outer coating...."
Great question.
Clearly, this new technology will prevent the accidental overdose. I assume the undigested pill(s) will simply pass through the digestive tract.
But, how hard is it to tamper with or bypass? If it prevents unintended overdose, there is good value here. If it can't be tampered with or bypassed, there is tremendous value here.
Drs. Isa/Amina Odidi are definitely in the driver's seat, in that they control 30% of the outstanding shares.
The big question: what other competing products are out there? So far, it seems to be a relatively new area of drug research/development.
Just saw this posted by someone on Twitter:
Jessica Merrill
?@Jessicaemerrill Just talked to Purdue CEO Mark Timney at BIO CEO, who says 2016 is the year for transformational M&A.
Here's hoping IPCI technology is deemed "Transformational" :)
ADDENDUM:
And then there was this tweet by Luke Timmerman:
Luke Timmerman ?@ldtimmerman · 3h3 hours ago
Mark Timney of Purdue Pharma pushing to raise profile of private co, says he's looking to buy a platform, something transformative #BIOCEO16
This can only be good for Abuse-Deterrent formulations, such as IPCI's:
Califf, FDA top officials call for sweeping review of agency opioids policies
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm484765.htm
I'm not so sure that the FDA would object, and even if they did, it's not their call.
For TKMR drug to be used, it would take a recommendation from WHO, approval by the governments affected (Guinea, Sierre Leone, Liberia), and someone to pay for manufacture of the drug. WHO's budgets have been slashed in recent years, so it would have to be one or more governments and/or private organization.
Even then, there may be difficulty getting the citizens of these nations to agree to 1 or more infusions of the drug, as there is tremendous superstition and in some regions distrust of the governments and healthcare workers.
dstx:
Thanks for posting this info.
What a messed up system. More important how you look to your boss (Congress) than to your client (generic drug companies). And the client pays the bills.
Typical government...less efficiency for more money.
Nowwhat2 (RE: Bre-X):
Wow...you brought back some long-ago memories with Bre-X Minerals (mid-90s?). I bought it at $2 and sold at $5 or so. I did the smart thing, like KareninCA, and ended up taking profits way too early, missing most of the massive increase in price.
As I recall, once the fraud was suspected (Barrick mysteriously backed out of a joint venture deal), I think it tanked from the $200s to single digits over several months. Project manager jumped (or was pushed?) to his death from a helicopter, fraud was confirmed, and then it was ultimately delisted. I think the ex-CEO was murdered a few years later in a "home invasion" in the Caymans or some other Carribean island.
Tough to make up stories with this much intrigue! Tom Clancy-esque.
lol! Yeah, today or some time this week, I hope.
PAR payment tomorrow? Timing seems right.
The Confidential Treatment Order doesn't look like anything to get excited about.
With a little deduction, I'm quite sure this relates to the agreement with PAR for Focalin:
- IPCI/PAR received approval to market/distribute Focalin on November 18, 2013.
- The IPCI/PAR Focalin agreement is for 10 years.
- The SEC document states that the confidential information will not be released to the public through November 18, 2023.
Wish it was something new, but I don't believe it is.