"... yet you take the time to research the short position ..."
I'm guessing from that comment that you - who actually owns shares - don't know that "researching the short position" involves just hitting a bookmarked link - typing PRKR in a box - and hitting a button?
I'll look forward to you giving us the heads-up just before you hit the "buy" button - so that we can all see the trades going through for the number of shares you tell us you're buying.
I'm sure you'll want to leave no doubt that you're really buying shares.
The Arikace clinical trials were never about the efficacy of the antibiotic.
The amikacin payload within Arikace is already approved by the FDA and EMA.
There is no question it kills Mycobacteria (NTM and TB) and Gram-negative bacteria (Pseudomonas, Klebsiella pneumoniae etc) which are resistant to the vast majority of antibiotics.
The Arikace clinical trials asked just three questions -
1. Does Arikace deliver an effective concentration of amikacin to a pulmonary Gram-negative or Mycobacterial infection?
2. Does delivery via inhalation prevent the serious adverse effects which currently restrict the use of amikacin to infections resistant to first-line antibiotics?
3. Does the liposome carrier cause adverse effects?
Arikace has now passed all three tests.
Proof that Arikace safely delivers an effective concentration of amikacin to Non-Tuberculosis Mycobacteria in the lungs is also proof that it will safely deliver an effective concentration of amikacin to Mycobacterium Tuberculosis in the lungs.
Amikacin injection is currently a top-ranked therapy for Multi-drug-resistant Tuberculosis. Worldwide an estimated 630,000 currently develop MDR-TB each year.
The Chinese regulatory body recently pushed through expedited approval of Bedaquiline as an additional therapy for the estimated 120,000 Chinese who currently develop MDR-TB each year.
Arikace is far safer than Bedaquiline. The recommended 24-week course of Bedaquiline would cost around twice as much as the course of Arikace which converted 25% of trial participants suffering from drug-resistant NTM to culture-negative in just 12 weeks.
To my knowledge no analyst has ever mentioned the potential use of Arikace as a therapy for MDR-TB.
Either I'm talking utter drivel here .....
Or these analysts don't want retail investors to know that INSM is another AAPL - until all of their well-heeled friends have accumulated as many shares as they can afford at the lowest price the analysts can engineer.
I'm convinced INSM is massively undervalued at the current price - and that nobody could now offer a credible valuation calculation to justify a share price anywhere below $50.
But realistically, how many investors CAN there be still holding shares today who are blissfully unaware of how ridiculously low is the current share price?
I suspect at least 95% of today's volume was day traders trading in and out. For somebody to accumulate serious numbers of shares, somebody else would need to sell serious numbers of shares (rather than sell, and buy back an hour later).
That's the bit I can't see - how many shareholders can there be who would reduce their holdings at the current price now that it's clear the NTM study was successful?
I'm not convinced of that. For anybody to be buying big time somebody else would have to be selling big time. You'll know when the big time buying starts - the price will be rocketing towards $30.
Btw - for the record, I only ever suggested jimmi / willy_wrangler as alternative ids of yours. You're as dissimilar in outlook to Kevin as is the DHW to Bandeh.
No cures - no immediate US filing expected = Price target $30
25% cures - immediate US filing expected = Price target $30
Just goes to prove that analyst price targets are often set at no more than a given percentage gain from the current share price.
Sadly - for retail investors in particular "the share price says it all".
Professional investors know only too well that because bad news causes a share price to drop, if they engineer a drop in the share price they can make good news look like bad news.
Yesterday's results were unbelievably good. Few followers of Insmed would have predicted that in their wildest dreams. If the share price had gone straight to $50 everybody would have understood why.
But instead it was business as usual.
Yesterday's results also started the clock ticking on commercialisation partnerships in Asia.
Proof of efficacy in Cystic Fibrosis will have had little bearing on future sales of Arikace in countries populated by people of non-European descent. Chinese and Japanese don't carry the CF genetic mutation.
But there is now solid proof of Arikace efficacy against pulmonary mycobacterial infections. A leak that Insmed is now in partnership discussions with one of the big pharmas would drive some spectacular share price appreciation.
A revisit of something I posted yesterday -
If I was the Chairman of Merck I'd be on the phone today to Hayden - looking to cut a deal with him before another big pharma does so, to develop and commercialise Arikace in China as a therapy for MDR-TB.
An estimated 120,000 Chinese every year are currently developing MDR-TB - and being treated with toxic antibiotics such as amikacin injection which causes permanent loss of hearing.
The Chinese health authorities recently approved Bedaquiline under their accelerated approval process as an additional weapon in the war against their MDR-TB epidemic.
Here's the CDC-recommended regimen -
[ The recommended dosage for bedaquiline is 400 mg once daily orally for 2 weeks, followed by 200 mg three times a week for 22 weeks taken orally with food in order to maximize absorption. ]
The price of 24 100 mg tablets is somewhere north of $4,000.
Therefore the recommended CDC regimen would entail 188 tablets, with an overall cost of over $31,000.
A 12-week course of Arikace would likely cost somewhere around half that - without the risks associated with Bedaquiline.
Merck already has a substantial revenue stream from its sales in China.
Haven't listened to the CC since I heard it live, and much of that is now little more than a blur.
But the first analyst to predict Arikace will be used for MDR-TB will blow this share price manipulation wide open.
And let's be realistic here. The top analysts currently covering Insmed wouldn't be in their jobs if they lacked the intelligence to connect the dots between solid proof of efficacy against drug-resistant NTM and likely efficacy against drug-resistant TB.
The analysts have never mentioned MDR-TB simply because it hasn't YET suited their agendas for the share price to really take off.
Also well worth revisiting a Bloomberg News article from February last year -
One of the most tantalizing new programs now being rolled out at the FDA is its brand new category for "breakthrough" drugs, offering a select number of companies a chance at a shortcut to the market based on early-stage data for transformational new therapies.
So when Janet Woodcock, the influential director of the FDA's Center for Drug Evaluation and Research, started outlining how the program will work--indicating that a company can move from an expanded Phase I directly to commercialization, Bloomberg reporters were paying close attention.
According to the business news wire, Woodcock says that companies which earn breakthrough status will have the ear of the agency.
"We expect many of these would come available very quickly with Phase I data," she said.
So far, we know that Vertex ($VRTX) has won breakthrough status for two drugs for cystic fibrosis, the approved drug Kalydeco and the experimental VX-809, now being studied as a combination therapy.
According to Woodcock, a third drug has been anointed with the special status. And developers have submitted 18 for review, most of which are for cancer.
Biotechs have been paying particularly close attention to this new, infinitely shorter path to the marketplace.
A breakthrough designation would revolutionize their commercial prospects, upending some well known methods for building value through long-term partnerships with Big Pharma--which can easily take years to complete.
Whether the FDA will allow smaller companies with less experience dealing with the FDA on the ultimate inside track, though, will be interesting to see.
You need to understand how he sees things in order to understand his posts.
Because he gets a clinical benefit all the time from the cream he uses on his haemorrhoids he can't see how it could be such a big deal to the FDA.
Perhaps there are one or two professional investors out there who know it's far easier to persuade retail shareholders to part with seriously-undervalued shares than it is to acquire them from other professional investors who understand valuation.
"What today's news does is eliminate any debate about the clinical meaningfulness of the data," said Andrew Fein, an analyst with HC Wainwright & Co.
I'll take that sort of "failure" any time - solid proof of clinical benefit instead of the hoped-for evidence predicting a clinical benefit.
Last July the price was only able to stay at that level because the BOD released supplied several million shares priced at below $10.
Who is now going to sell any serious amount of shares for anywhere near the current share price?
With the Cystic Fibrosis results alone the shares were significantly undervalued at $20.
I can't see that my opinion of how the FDA is likely to view these results could be of any more value than the opinion of anybody else.
But fwiw I personally can't think of a reason why the FDA would want to delay access to a drug now proven to have delivered a substantial clinical benefit no drug currently available to this seriously ill patient population can deliver.
You need to ask yourself if today's results met the criterion for accelerated approval under the new legislation of being "reasonably likely" to predict a clinical benefit in a severe unmet medical need.