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Does him stated he has no conflicts at the beginning? Con guys, let's hunt him
Name of the guy, list of ELTP shareholders...then email to FDA and SEC about conflict of interest.
Email to IPCI as well.
" the guy who flat out stated that he was sure pictures of blue Rexista users would show up on the internet in days"
I believe he is WZ, I'm serious. can we get his name? You never know
Samsa I believe the lack of a CEO is the problem, someone with the ability to present, linking science, strategy and driving the discussions on the proper path.
Too many time spent on the dye...who cares about the abuse deterrence.
I agree it's a close match and I'm surprised how much weseal was able to influence the panel
It is my first AdComm, so I'm trying to orientate myself.
From a logical point of view, questions n 3 is the only one with issues...the dye. But again from a logical point of view the question pertains IV and there should be no problem with the dye via IV as the toxicologist explained during one of the initial presentations.
Still I'm frustrated about lack of sata, but the proprietary aspect has to be considered.
To me today it's very stressful
If I understood correctly FDA said that the dye formula is proprietary and the review of the excipient risk will be carried out when they ponder about the risks-benefits when it comes to final approval.
This is what I got from the FDA lady
Samsa, thank you so much for the incredible contributions you make to this board.
I bet Reuters' contributors (!!!??!!) received an email on what to extrapolate by someone writing on this board.
Indipently of AdComm outcome but the timing and subject of the article really seems to come from someone here.
Let's see what happens in the next two days.
Glta
It was during Q&A following a company presentation, don't remember exactly in which one, around one year ago.
Sorry for not being more precise but I am on a trip with just my phone
Sessions Said to Target Opioid Care in Crackdown on Fraud
- Hundreds of arrests said planned in cities across the country
- Actions target opioid treatment fraud under Obamacare plansBy Michael Smith, Anna Edney and Zachary Tracer
(Bloomberg) --
Attorney General Jeff Sessions is poised to announce a major law enforcement action this week targeting health-care fraud, focusing on opioid treatment programs exploiting Obamacare insurance plans, according to two people familiar with the matter.
In what is described as a nationwide sweep with hundreds of arrests being carried out across the U.S., the Justice Department is cracking down on fraudulent claims made to some of the nation’s biggest insurers, said one of the people. People who run drug addiction treatment centers that have filed bogus claims and those who have filed reimbursement claims for drugs they then sell illegally are among those to be charged, the person said.
Arrests will be carried out in cities including Miami, Chicago, Detroit and Los Angeles, the person said. Scores of arrests are expected in southern Florida, which is home to hundreds of residential drug addiction treatment centers, said the person. Federal prosecutors, some of whom have been working on cases for a year or more, were directed to accelerate their efforts in time for this month’s operation, the person said. The Government Accountability Office did an investigation and found last year that the sign-up process for the Affordable Care Act exchanges was "vulnerable to fraud."
OIG Report
In a related action, a report on opioid use is expected to be released Thursday by the Office of Inspector General for the Department of Health and Human Services. The OIG investigates waste, fraud and abuse in government health programs, including Medicare and Medicaid.
Under the continuing crackdown on opioid abuse, Mallinckrodt Plc, a maker of pain medications, on Tuesday agreed to pay $35 million to resolve allegations that it failed to notify the Drug Enforcement Administration about suspicious orders from pharmacies and pain clinics. The company denied it had behaved improperly.
This comes as a fight brews in Congress over how much money to allot for opioid treatment and as Republicans spar over how to repeal or replace the Affordable Care Act. Some Republicans want more funding to help states combat the opioid addiction epidemic, which is estimated to have killed 60,000 Americans last year. Changes to a Senate bill expected to be released later this week may include more money in addition to other changes, but it’s unclear if it will secure the 50 votes needed to pass.
While the government has been doing health-care fraud roundups every year, past actions have focused on people who were defrauding government programs, including Medicare and Medicaid. While those types of cases are still part of the roll-up, this year the emphasis will be on fraud against private insurers by treatment programs that have taken advantage of Obamacare’s more generous coverage, the person said. Both of the people who discussed the initiative asked not to be named because they weren’t authorized to speak publicly about it.
A Justice Department spokesman declined to comment.
Doog,
you are so right on this
"we were going to be much further ahead on their generics front..."
if only we already had the other 2 ANDAs under the MKN deal approved, but here FDA has been proven to be corrupted, lazy and on the part of big pharma instead of patients.
Would love to see a Pristiq approval-surprise before the 26th of July
Samsa,
I agree with everything you outlined; the damage these flip-floppers made to the company image I think is more than ever clear over the recent weeks: in fact a positive momentum has been building up, in terms of newsflow regarding the opioid drug landscape (competition issues) and IPCI about to reach paramount catalysts. This usually is what determines the speculative push in biotechs (and not only); but as we know the speculative part in IPCI stock value is simply = to zero.
Tek,
what you mean when you say professional investor ? If you mean professional indipendent traders then I can agree that they can adopt the strategy of trade a price range in order to increase their share count while not adding initial cash.
But when it comes to institutional investors then you may be wrong: they tend to buy and stick with their Investments until major value unlocks.(I can tell you without any doubt and by experience)
Someone trading with 100K usd is not an institutional investor, unless there is an accumulation in tranches going on, but not filp-flopping.
What you say about cash available for the company (and you have been repeating it for quite a while) is correct in absolute terms, but when you look into perspective: AdComm, Purdue lawsuits likely to be settled, political need to find answers to the opioid gigantic issue, competition products starting to being questioned-deeply examined-delayed, etc by the FDA- then you understand that a stock without bad reputation would have likely made a remarkable performance since the beginning of the year(regardless of cash available). I could make you examples, but I know you are well aware of other companies making speculative runs based just on analysts reports, a news article, ...and the like.
that said, it's now IPCI time to deliver and to have some good fate as well.
The price will follow...likely with a bumpy path, but IF Prodras works many of us will have an IPCI T-shirt as their preferred one ! LoL
All JMHO, obvisouly
Tek,
IF ipci gets green light for the labeling I think Rexista could be in the right place at the right time.
As you correctly pointed out, potential market share for ipci is going to increase incredibly (provided we ge the labeling) ...even more if FDA blocks other drugs already in the market.
Will we longers be rewarded this time ?
I hope that the vast majority of people here writing will start to see their long time frustration becoming an increasingly lovely journey.
Agreed on everything you wrote
"… each of those two growing markets is but a percentage of the global opioid pain med market projected to be $42 billion by 2021."
"non-abuse-deterrent opioids represent 98% of all prescriptions in the market."
"While there are ADFs that have been approved by the FDA, they only comprise 2% of the market."
we just need a small % of the total market (42billions), we don't necessarily have to be the best of best to see IPCI value multiply.
and when you see the big co. being object of gov/public lawsuits you understand that they NEED to buy/takeover if they want to keep/increase they market share.
in conclusion, considering all the buts and ifs around IPCI, we are likely to be in the right place at the right time...there is enough.
JMHO
let another ANDA be approved (of those included in the Mallinckrodt deal), another pop in share price followed by the usual drop, then a positive news from the Purdue lawsuite, followed by the usual down in the price...
... an we start to get into the potential takeover targets dossiers. Just my feeling.
GLTA
The disconnect here is becoming beyond incredible
Also don't forget...to get free YOUR vaporware
My feeling too. It's now time to start those trials...or even better, put out a PR where they say they already started.
This is reinforcing the idea of Mallinckrodt as the preferred partner for Rexista/Prodras + Regabatin. They are exiting all the low margin businesses.
To be closely monitored to have an idea of possible IPCI partnership announcement. Mallinck now knows Intelli pipeline and IF they liked it...
I believe any civil conversation is impossible to do with a guy like you
"many of whom may not know IPCI is planning to poison all of their customers with a drug that is known to cause severe sepsis and death. Many of them may not understand that PODRAS is snake oil and will never be anything more than a grift to sell stock to suckers. "
maybe a good doctor is needed here...but not for IPCI products analysis
Amigo,
"I've seen from them what the current valuation should be."
I thought target prices had the usual 12 months horizon.
As I repeated...analysts reports Is a basis...you go through assumptions and projections and then elaborate based on your research and decide where disagree and which mod you wanna do.
And then there is the other 'shortcut'... something? the market have been using since many years, with its good and bads, the multiples.
Earnings lovers and forward earnings are welcome...but when I read a 20 p/e applied to a microbiotech...and I'm not necessarily talking about you.
But I respect your idea of a stock correctly at 2, just would like to know the assumptions you make.
And I would like to know your 12months projections, which is what an investor should consider more importantly than current price.
Guess you are a professional analyst or similar.
I tend to use analyst works as a basis of my job...as a basis, I repeat.
If I had to build by myself a spreadsheet for each and every stock I consider....
Therefore, respect, but if you have numbers you can show us why current t valuation is fine, on which assumptions, on which level of risks.
Not everyone is an analyst
Amigo,
If I may...the shortcut answer is take analysts target price and discounted it to now (so 1 yr back).
You can use two different discounts rate based on the level of risks you assign to future achievements in the next 12 months.
Seems reasonable to me...do you agree?
I have not a calculator here but it seems hard to get a 2 as fair valuation.
Jmho
Samsa,
agreed, not yet, that wasn't what I meant.
I share your thoughts about Odidi and the share price; I if we see a mispricing than at some point some other bigger than us will.
Odidi has a figure in mind, and I think is way above current levels.
One step a time IPCI will progress with some other developments and likely the share price will continue to languish...until..it won't anymore.
Samsa,
recently we are very much aligned.
IPCI too much often referred to like as it was a big pharma; earnings, CF and so on.
Then you look at all the oher micro biotech and you see that the valuations and dynamics are completely different.
as you wrote, my expectation was for a consolidation in the 3s, while observing 1/3 of mkt cap going away while the company progresses looks odd.
as I wrote last week, I respect everybody's point of view but the disconnect between price and company developments looks clear.
still many uncertainties and issues, I know it very well, but that is the very nature of biotech investing.
There is one more thing I can tell...the more you have a disconnect and the more a buyout becomes an option
GLTA
Ok Amigo,
Apologies for making wrong assumptions about your statements
You ask about red flags...I have a black flag; and it is due to the awareness that the stock is controlled as never seen before (by me).
My black flag tells me Odidi is not a good CEO but he can deliver whatever...the stock has an insane dynamic.
Wim I respect everybody, long short neutral... it's fine.
I don't like the self confirmation bias.
when somebody is proposing reasonable considerations for explaining counterintuitive share price behaviour I feel something inconsistent.
I would have expect ipci to range between 3.25 and 2.75 over the last 12 months...with temporary extensions.
When I read someone saying @3 is fairly valued, @ 2.50 fairly valued, @ 2.20 same, @ 2.00 same....and this in corrispondence of a slow company improvement...I don't get it.
Just say from the beginning ...to me it's a 1.5 stock and I'm gonna short it or wait before buying until that level
Yes Amigo,
A company files an NDA and the stocks goes down, gets an approval and the stock goes down,
...
Positives are already priced in.
So it seems that you and Tek are saying that this stock can only go down - and you are consistent with your perspectives I guess.
But usually stocks have ups and downs based on their company developments.
And than there is the magic.... trading range.
I strongly agree with many of the issues you and Tek raise, but it is at least strange to have a positive announcement and a negative market reaction.
That's your business, so I believe you support the idea that whatever happens it is legitimate assume that the share price can JUST go down.
It has more weight the Odidi debenture than Seroquel being marketed.
I am long time investor here, but I also make many intraday and speculative operations in other asset classes. So I do know very well both sides...long e Short.
But please, one time, you and Tek could admit that a positive news is usually followed by green prices.
After that you can even say...guys...this stock is a cash machine...just short it, don't look at co developments.
Odidi is hated...just short.
With all due respect
We have professional shorters and not traders. One of them I believe used to write here, nowadays much less.
They are short bias funds, mainly active in the biotech space.
They are not giving up unless they find a bigger sharq on the other side.
No news, no fundamentals, they just crush the stock simply because they are the biggest sharq in the pool.
They will stop when they have our shares.
And how can this possible happen?
A huge flash crash, like for instance we go below 1 in a few minutes....and that's it.
Stock history distroyed and everybody staying away for ever.
That's their target.
We are just in the hands of an eventual bigger sharq.
Just a feeling
Cysonic,
More than happy if I can help you with the SEC, maybe Canada authority it's better. I think naked shorts and fake news could be brought to their attention. Also understanding ultimate beneficiaries of shares...likely someone not disclosing its position as per law.
Tekterra defending the strategy of the Group...so for you it's ok to have a small biotech slowly delivering and approach cash flow positive status while in the mean time having share price constantly downwards.
Broker offering 50% for having ipci shares lended makes one wonder how insane this situation is... that's the rate usually offered for deeply distressed stocks.
Hope the Group, and those of them writing here, will get burned and prosecuted.
it really seems illogical
Here we don't have a real hedge fund, but the famous Group of f.*ing id.i.*ts which are trying to push Odidi down from the driver seat (and closed into the lab) and taking control of the company at ridicoulous prices.
Odidi better come out with a big partner soon, or we dive to new lows.
this stock has been played like a toy
ah ok,
approval was already priced in
and... some profit taking after the huuuge run up...
LOL
unbelievable
this stock is dead. we are RED
only a meganews could move it upward seriously.
I would love a Pristiq approval by the end of June.
Looking at the oldest filings, when you see an ANDA pending for 7yrs, you realize the corruption sorrounding FDA.
Any idea on the possibile Canada ANDS Seroquel timeline ?
jedijazz,
"for sure" doesn't belong to IPCI.
For sure
LOL
When their shorted shares will be bought by long holders (institutions) then but just then...game over.
Hope this process is about to start
Exactly because FDA received more funds and resources to streamline processes and make drugs hit the market faster, somebody has to scream "what the heck are they doing"
there are people, politicians and journalists mainly, who can become very aggressive if they understand that a story could push them in to the limelight.
I'm therfore exorting whoever has the ability and the energy to address this issue to the media and politics, maybe some republican who wants to stress out the corruption at FDA to have it completely reformed.
We gotta fight for our IPCI, but truth is that this has been going on over and over for years...corruption, as simple as that.
Samsa, Wimus, Doog, or any other with english mother Language,
I believe that you can try to prepare a very short dossier, with the story of what just happened, with she screenshot of the approval and then the current lack of everything related.
Then have it sent to some journalist, politician, activist...sometime from a small snowball you can get an avalanche
To those close by to Toronto,
could you pls pay a visit to mr Odidi and see if he is sleeping or simply just forgot we need to partner ?
If he remembers well he can either choose among Gluco, Keppra, Rexista, Regabatin...
ok, don't wake him up just for keppra.
in the mean time..down we go, thanks to two kids with their poderous savings who are starting to learn how a short works.
Cysonic,
I have the hope it is just an FDA database issue, but then why no just send a communication the old way...like a fax ?
I don't know, maybe they have internal rules such as the website is considered as reference (from legal point as well ?).
It really seems that all the approval activity is somewhat odd since may 1st.
The fact is that the damage is already there (daily revenue/profit loss) and the longer it takes the the stornger the pressure will be on share price.
I'm still positive, but honestly FDA seems like a casino and not the most important autorithy in the meds space.
GLTY