Klebsiella now has a CDC 'threat status' of Urgent - because strains have evolved, and can transmit to other bacteria, an enzyme which inactivates the Carbapenem class of antibiotics.
These results are from a study at Sultan Qaboos University Hospital from July 2005 to July 2007 of antibiotic resistance via extended spectrum beta-lactamases (ESBLs), during which they identified 301 ESBL-producing Escherichia coli and K. pneumoniae strains isolated from clinical samples -
Overall Piperacillin-Tazobactam susceptibility was 57.9 (64.4% E. coli and 43.6% Klebsiella pneumoniae).
Only 29.6 % of ESBLs (24.9% E. coli and 39.6% Klebsiella pneumoniae) were ciprofloxacin susceptible.
98.1% E. coli and 93.1% of Klebsiella pneumoniae were susceptible to Piperacillin-Tazobactam plus Amikacin combination.
73.7% E. coli and 61.4% of Klebsiella pneumoniae were susceptible to Piperacillin-Tazobactam plus Gentamicin combination.
96.7% E. coli and 91.1% of Klebsiella pneumoniae were susceptible to Ciprofloxacin plus Amikacin combination.
41.2% E. coli and 51.5% of Klebsiella pneumoniae were susceptible to Ciprofloxacin plus Gentamicin combination.
"Conclusion: The ESBLs from Oman have similar resistance pattern as those reported from UK and USA. This resistance decreases when these drugs are combined with Amikacin. All ESBLs are susceptible to Carbapenems. However, carbepenam overuse can lead to emergence of carbapenems resistant gram negative bacilli and ESBLs.
Combination of Amikacin plus Piperacillin/Tazobactam is a feasible empirical therapy for ESBLs."
The reference to "empirical therapy" is key - emergency antibiotic treatment provided at a point when the pathogen has yet to be identified via laboratory analysis.
From the 2012 FDA-sponsored workshop on Non-CF bronchiectasis -
"in the unit, in the hospital, we frequently double coverage people with pseudomonal pneumonia, for example, or gram-negative pneumonia, or just empirically before we know what anything is."
Checks - a company at Insmed's stage of development has little choice but to issue shares until such time as it has a product on the market generating revenue to pay the bills.
Nobody can reasonably criticize the Board for doing that, or for doing that in a manner which ensures there is always enough cash already in the coffers to allow development to proceed at the optimum speed.
But it's the TIMING of the share offerings since Lewis arrived which are suspect , starting with that first toxic dilution just after Lewis arrived in 2012 - which coincidentally happened just a few months after the Company had guided that the Hercules financing deal ensured there was enough cash to fund operations into 2014.
Three very lucky investors got millions of shares priced at around $4 a share. We got diluted by 20% - in exchange for barely enough cash to pay the bills for an extra quarter.
Then came the second offering last July - priced below $10 when the price had exceeded $14 just two months earlier just on the EXPECTATION that Arikace would succeed at Phase III.
Why did the Board, with Phase III success already in the bag, price an offering at 50% of the average analyst valuation so soon after the good news - instead of waiting a few months until the price was over $20?
Lewis - "That's going to be a dialogue with the FDA. And frankly out of respect for them we will not be coming out with a comment on whether we're filing or not when we have the data release at the end of March. We're going to wait until we have had dialogue with them based on the data we have to inform where we go from here."
They'll be careful to avoid any guidance which might be read as taking the FDA for granted.
Reminds me of all those dreadful lies he told about his "friend in New York" - who somehow managed to predict in great detail every single event which worked in PRKR's favour, like the Markman ruling - but was unable to predict a single disappointment for PRKR, such as the failure to procure the verdict of wilful infringement upon which Longprkr's expectations of a massive profit via a treble-damages award were dependent.
"Every time I tell ... my long position is up 200% in 2+ Years, he acts like a petulant 6 year old"
I wonder if the usual suspects will try to walk the share price down by more than $10 tomorrow? Ideally they'd need to drop the price to around $2.50 to be reasonably sure of engineering our delistment.
On a more serious note, I suspect our free-float-adjusted weighting within the index hasn't been adjusted since last July's share offering. If so, our current weighting would be based on a share price of around $10.
Anybody looking to make life uncomfortable for the Shorts could do so by running the share price up by a dollar or two tomorrow. The tracker funds would need to be holding a considerably greater number of shares for a weighting based upon $15 instead of $10.
Conversely, the Shorts could try to drop the price significantly lower tomorrow.
I've never at any stage had a financial interest either directly or indirectly in PRKR. I originally came here out of curiosity because trublvrprkr was pumping it on the INSM board.
Everything else you might be interested in knowing you should be able to work out from my choice of id.
Guess it depends upon how the FDA chooses to interpret "reasonably likely to predict clinical benefit" -
[ The Secretary may approve an application for approval of a product for a serious or life-threatening disease ... upon a determination that the product has an effect on ... a clinical endpoint ... that is reasonably likely to predict ... clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. ]
But if the Arikace label simply mirrors the amikacin sulfate label - for the treatment of serious pulmonary infection by amikacin-susceptible Gram-negative bacteria and mycobacteria* - that would just about cover it all.
* the mycobacteria would be an addition.
Yep - they were walking the price down as usual, and Bam!
Hope the seller didn't get careless and sell them to a stranger :-)
One of the less obvious significant benefits of the use of Arikace in MDR-TB was highlighted in the EMA COMP minutes posted by bwd -
[ In addition, the possibility of using amikacin by inhalation has the potential to result in a major contribution to patient care by allowing the outpatient administration of the product. ]
If that factor is viewed as potentially "a major contribution to patient care" in countries with a high standard of health care, imagine how much greater the impact would be in an African country with an epidemic of MDR-TB.
When a child is infected he/she can be moved to a medical facility where one physician can treat a hundred patients. When an adult with a dependent family is infected, someone trained to administer intravenous injections must visit him/her daily for at least six months.
There must be a considerable number of health care personnel who currently spend virtually all of their time travelling - day after day covering the same round of patients scattered over a large area.
But help is on the way :-)
For me the most striking fact from that attempted deal is that PFE made an offer very close to AZN's asking price - despite the fact that said asking price was based upon projected revenue of $45 billion by 2023, half of which AZN expected to be earning from products currently in development.
But the point is that buyout valuations are based upon projected revenue in ten or twenty years time. In just ten years time most of the drugs currently delivered by injection or tablet to treat pulmonary conditions can reasonably be expected to be delivered via Insmed's liposomes.
Boring. Your pathetic attempt at deception doesn't tally with your claim that the shorts were "in a panic".
The analyst prices you rely on are not buyout valuations. They are nothing more than predictions of the share price in a year's time.
It does my brain in that anybody would actually believe an owner would sell a multi-billion dollar asset for a given price for the sole reason that the price is x% higher than the current share price. I suppose you would have argued when the share price was $4 not so long ago that $6 was a fair buyout valuation?
Here's a clue as to what happens in practice -
[ Is AstraZeneca "realistic in what it believes 'fair value' is?" Timothy Anderson, a pharmaceutical analyst at Sanford C. Bernstein, said in a research note Monday. "Projecting the worth of new drug pipelines is notoriously difficult, and drug companies and financial analysts alike are often wrong to the tune of billions of dollars, especially when going out five to 10 years. Drug development is just not that predictable."
AstraZeneca said earlier this month that it expects to achieve annual revenue of $45 billion by 2023 as an independent company.
The company, which has an attractive portfolio of cancer drugs, has repeatedly trumpeted the strength of its drugs in development, saying it is projecting peak annual sales potential of about $23 billion for those drugs by the end of 2023. ]
... is the fact that Lewis recently mentioned for the first time in an investor presentation the potential use of Arikace in MDR-TB.
It's common knowledge that most drugs used to treat MDR-TB are being used off-label. Therefore it's a reasonable assumption that regulatory approval of Arikace anywhere will result in off-label sales also. Any valuation from now on cannot ignore MDR-TB.
The Board can only issue eight million shares (20%) without our specific approval. Anybody looking to acquire millions of shares at this point would find only a small proportion of them available for sale at anywhere near this price.
It could well be that there are now more big players looking to buy shares via the next offering than eight million shares would accommodate - and that there is an auction of sorts taking place behind the scenes.
The Board would be in serious trouble if they issued shares to some investors for $13 a share, only to have other investors spread the word that they offered a much higher price.
I don't think we can rule out the possibility that the next offering will be priced on the basis of reasonable revenue projections.
From the recent guidance -
[ The Company expects current cash balances will be sufficient to fund operations into 2015. The Company plans to provide additional cash guidance in the third quarter once additional discussions with the regulatory authorities have taken place. ]