[ Contrary to the relatively robust regulatory system that exists in the United States, China has significant gaps and weaknesses in its regulatory oversight of the off-label use of drugs.
In China, the practice of medicine is relatively less regulated. Physicians are not prohibited by law from prescribing off-label drugs. ]
Fwiw - I know for a fact that the FDA has no power to prohibit off-label use in the US.
The promotion / advertisement of off-label use is prohibited in the US - as is importation of drugs for off-label use (though overlooked as long as the quantity imported is sufficiently small to be consistent with personal use).
I particularly liked this bit from that "biotech bubble" article -
Notice that it's almost always after a rapid rise in stock price that a biotech will open up a public offering of stock. Why? The increased value of the shares will help offset the dilutive effects of the offering ...
Given the lack of response to your plea - perhaps you need to face up to the fact that Insmed seems to attract investors with a "turn the other cheek" philosophy.
If there's anybody here who doesn't simply assume that we Longs are powerless to help ourselves, feel free to e-mail my good buddy fud.fighter2 at his Yahoo address so that we can kick one or two ideas around.
It would be on a confidential one-to-one basis - I've corresponded with a number of INSM Longs in the past on that basis.
It's pointless discussing such matters on a public board very likely monitored by those who have been profiting from the manipulation all these years.
For those same reasons you'd have to be willing to trust me with a non-Yahoo address (I would reciprocate) so that I know to whom I'm talking.
If a Long who is interested already knows my main address please e-mail me there.
That is exactly what I was driving at :-)
I'd be interested in knowing how many Longs do NOT assume there's nothing we can do.
"Needless to say, these nefarious people will eventually pay for their deeds."
While that is indeed a comforting though, I see nothing wrong with exploring ways of shortening the interest-free period.
OK. I would never try to initiate a discussion on religion, because I'm absolutely certain that nothing I could contribute would be helpful to a believer.
But I am curious as to the manner in which belief translates to everyday situations. If I remember correctly you recently put up a post about Easter, which promptly disappeared. If I'm correct, this would call for the "turn the other cheek" response.
Do you also feel it's right to turn the other cheek when the usual suspects seize the opportunity of negligible demand for the shares at a time when the biotech sector is experiencing a major sell-off to walk the share price down by 40% in less than two weeks from a price which was already substantially undervalued?
Having been bought up by a devoutly religious mother I remember two apparently-contradictory bits of advice -
1. Turn the other cheek.
2. God helps those who help themselves.
After years of therapy I guess I ended a believer of No.2.
Anybody else here with a similar outlook?
Thanks Edge - reminder of the earlier clue regarding anticipated timeline:
"Beerse, Belgium, (March 06, 2014) - Janssen-Cilag International NV (Janssen) announced today that the European Commission (EC) has granted conditional approval to SIRTURO® (bedaquiline) in the European Union, for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients, when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
The decision from the EC follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the approval of bedaquiline on December 20, 2013."
I guess I need to point out that a positive opinion on Orphan designation is not a positive opinion on whether or not whether or not the EMA should approve Arikace on the basis of Insmed's anticipated filing for approval in H2.
Would imagine the filing will go to the CHMP - which will in due course make its recommendation - followed hopefully by EMA approval three months later.
If anybody here fancies sharing the load, the timeline could be firmed up with a a recent example or two of the time from the filing for approval to the time the CHMP announces its decision.
Who can say? The guys managing multi-million dollar funds didn't get where they are without being good at seeing how to make the optimum profit from a situation.
It has suited them to bide their time. And with no significant buying pressure it's easy for the manipulators to walk the price down.
But my gut feeling is that it's only a matter of time before a big buyer is the first to blink. When that happens I'm not expecting anybody to be selling significant numbers of shares for less than $20 - unless they are expecting to buy them back via a low-priced offering.
Anybody sufficiently gullible to be suckered by the "INSM is simply following the market" explanation might learn something from the last four closing prices -
The World Health Organisation has set a target of virtually wiping TB from the face of the planet by 2050.
How long will it take to eradicate the infection from the two billion people Worldwide estimated to be latent carriers?
It's not reasonable to expect people who don't suffer any symptoms of the disease to be compliant with an antibiotic regimen which makes them ill.
Anybody owning a patient-friendly technology for delivering an antibiotic to the lungs seems likely to be in pole position for a monster revenue stream at some stage.
You'd have to think the WHO strategy would be to start with countries with a reasonable standard of health care and work their way down.
Might also be worth looking out for companies targeting the diagnosis of latent TB.
I wouldn't advise anybody to buy for the MDR-TB angle unless it's with a view to the medium/long term. The adoption curve is just guesswork.
From memory 95% of TB infection occurs in low and middle income countries - so in the near term the realistic target market seems unlikely to be anywhere near a hundred thousand.
Looking longer term - the WHO has set itself a target of virtually eliminating TB from the planet by 2050, which means that anybody owning a patient-friendly technology for delivering a therapy to the lungs would seem to be well-positioned for an eventual market of two billion people.
It would be useful to know when the WHO plans to make a start on that :-)
From Insmed's 10-K -
[ In 2009 and 2012, we entered into a cooperative research and development agreement (CRADA) with the National Institute of Allergy and Infectious Diseases (NIAID) to design and conduct our phase 2 study of ARIKAYCE in patients with NTM. NIAID has also agreed to provide biostatistical advisory input in connection with the phase 2 NTM study. If we decide not to continue with the commercialization of ARIKAYCE in NTM, NIAID will have the right to complete the clinical trial. Further NIAID may elect to pursue its rights to obtain license rights to certain inventions made under the CRADA. ]
[ NTM patients average 7.6 antibiotic courses per year (SDI Healthcare Database, July 2009). ]
If Insmed had trouble in finding 100 patients with an NTM infection chronically resistant to the standard antibiotic regimen - it seems a reasonable conclusion that the vast majority of the 50,000 US patients diagnosed with an NTM pulmonary infection each year are adequately served by the "antibiotic courses" mentioned in Insmed's 10-K.
And one suspects the National Institutes of Allergy and Infectious Diseases has far more important demands upon its resources than the 100 or so US NTM patients for whom a combination of old age and a serious underlying pulmonary condition results in an NTM infection which doesn't respond to the standard antibiotic regimen.
The Generating Antibiotic Incentives Now legislation was signed into law in July 2012 - in response to the potentially catastrophic threat to public health posed by infectious strains of bacteria which have evolved resistance to first-line antibiotics.
The NIAID has those drug-resistant infectious bugs as its top priority. NTM isn't even infectious.
Why is the NIAID so interested in Arikace?
What did the NIAID expect the FDA to do if the study had delivered the results everybody was expecting - evidence that Arikace reduced the bacterial load of an NTM patient?
Assuming Insmed charges only $15,000 for a 12-week course of Arikace for MDR-TB - a share price of $20 today would be warranted by the anticipated use of Arikace two years from now by just 20,000 of the estimated 500,000 infected with MDR-TB each year.
That $20 share price would assume zero use of Arikace for either CF or NTM - and would be based upon a price/sales valuation multiple of 4, the value of that revenue stream to a big pharma.
A more reasonable price/sales valuation multiple for a company at Insmed's stage of development would be at least 8 - meaning that a current share price of $20 would be warranted by the anticipated use of Arikace two years from now by just 10,000 with MDR-TB -
$15,000 x 10,000 x 8 x 0.8 x 0.8 / 40,000,000 shares = $19.20
You'll believe it when the professional investors finally show their hands - and the analysts following Insmed finally mention MDR-TB - and the share price is over $100.
But for now almost everybody who reads this will find the current share price far more believable - and fail to make the most of a once in a lifetime opportunity.
1. The FDA's Most Wanted list -
[ (g) Qualified Infectious Disease Product- The term 'qualified infectious disease product' means an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by--
..... (1) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or
..... (2) qualifying pathogens listed by the Secretary under subsection (f). ]
[ (f) Qualifying Pathogen-
..... (1) DEFINITION- In this section, the term 'qualifying pathogen' means a pathogen ... that has the potential to pose a serious threat to public health, such as--
.......... (A) resistant gram positive pathogens, including methicillin-resistant Staphylococcus aureus, vancomycin-resistant Staphylococcus aureus, and vancomycin-resistant enterococcus;
.......... (B) multi-drug resistant gram negative bacteria, including Acinetobacter, Klebsiella, Pseudomonas, and E. coli species;
.......... (C) multi-drug resistant tuberculosis; and
.......... (D) Clostridium difficile. ]
2. The NTM results -
[ The Company also intends to apply for Breakthrough Therapy Designation for ARIKAYCE in the United States based upon the culture conversion results. ARIKAYCE has already received Orphan Drug, Qualified Infectious Disease Product (QIDP) and Fast Track designations from the U.S. Food and Drug Administration (FDA) ]
3. Lewis last year -
[ ... in the anti-infective space generally, what we're seeing is a real engagement on the part of regulatory authorities where there is efficacy and safety to find a pathway forward to get these drugs onto the market - whether it's through breakthrough therapy, QIDP designation or indeed, just evaluation of final data outcomes, has been seen with other products as well. There's just a real need for anti-infectives generally and any arrow in the quiver is going to be welcomed by the regulatory authorities, we believe, both here and in Europe. ]
I agree with your observation that there seems no good reason for a share offering at this time.
But unfortunately the recent price manipulation is looking far too much for comfort like a repeat of the massive destruction of shareholder value the Insmed Board made possible last July.
We know that the net Short position increased by 350,000 on Wednesday's news.
7.8 million shares were traded on Wednesday. For all we know the net increase could have been the result of 4 million shares sold Short - with 3.65 million of those being sold to investors already Short who covered.
That would still have left an additional 3.8 million shares comprised of normal selling, normal buying and day traders who just profited from the drop and recovery (ending the day with unchanged positions).
There are only so many dumb retail investors out there who could have been conned into selling by the charade.
I hardly think it likely that many professional investors would simply gamble that the FDA will dismiss a statistically significant clinical benefit because the numbers for the primary outcome, though good, were less than statistically significant.
What reasonable expectation could a professional investor have had who sold thousands of shares, that other investors would in due course sell those shares back to him in at an even lower price?
To offer a slightly more pessimistic outlook than Jad's logical response -
It means that the manipulators had to sell Short another 350,000 shares to investors who weren't fooled by last week's charade of misrepresenting as bad news NTM results which were exceeded all expectations.
It means that sooner or later the investors holding the Short positions will have to buy back on the open market 3.4 million shares - mostly from shareholders who wouldn't dream of selling shares at anywhere near the current price - UNLESS the Insmed Board supports their manipulation by lining their pockets at our expense via an offering priced at a level which asks us to believe the Insmed Board sees zero possibility of Arikace being used as a therapy for Tuberculosis.