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Press notice in the UK
"How filtering blood may help to combat Covid-19"
" ... The blood-cleaning device was developed in the U.S. to treat sepsis, which can also spark a cytokine storm and lead to organ failure, and kills around 46,000 people in the UK each year. The CytoSorb device is already approved in the UK for sepsis.
"In April, the U.S. Food and Drug Administration stated it could help treat Covid-19 cytokine storms. In May, UK regulator, the National Institute for Health and Care Excellence, produced guidance on its use against the virus."
https://www.dailymail.co.uk/health/article-8707065/How-filtering-blood-help-combat-Covid-19.html
Caregivers have insurance policies and the policies most likely include provisions that protect the insurance company if the insurer ...
...followed by a list of prohibitions most likely including "uses medication not yet tested and approved by the FDA".
Your kin is just doing what his/her institution (and the insurer) demand he/she do, or don't do.
"April, 20, April 27, May 5, May 19, June 11, June 17, July 20, August 4...Leo has been looking for collaborators since April and apparently nobody has stepped up. Why?"
"No one has ever tried Coca Cola."
That's the only explanation for their continued advertising.
"There have been comments about big pharma colluding to smother IPIX."
Financed by the oil companies that "buried" the 100-miles-per-gallon carburetor?
“Global Antifungal Drugs Market is expected to rise from $13,719 million in 2016 to $17,718 million by 2023."
29 percent over seven years is "savings bank interest" territory.
What you said.
Might this be as significant as the discovery of penicillin?
If enough people banned him ...
This is the entire content of my Nov 30, 2018 posting:
Being an ex-accountant (like LE) I understand as G. Stein, CPA once wrote, "Revenue is revenue is revenue is revenue."
Thanks for finding that message of mine.
Perhaps I should send them a bill?
Most US hq'd companies expanded first in the USA, then internationally.
But not all of them.
AFLAC was enormous in Japan before tackling its "home" market.
A small US medical device company is also putting "international" first: https://cytosorbents.com
American kids grew up on Campbell's tomato soup; British kids on Heinz. Both are US companies.
IPIX management apparently understands that the ex-USA market is much larger than the USA market and perhaps easier to penetrate.
(Rockefeller was selling kerosene to the Chinese in the 1800's.)
Suggestions: 1.Buy a globe, 2.learn something about world markets.
I recommended "going international" in a post some time ago.
I'll try to find it.
Why doesn't IPIX go for foreign registration first?
I know of one US company based in New Jersey which has an innovative medical product. They are selling it in non USA markets probably because registration was much simpler than in the USA.
Antibiotic-resistant superbugs creating deadly risks for hip and knee operations
https://www.telegraph.co.uk/news/2018/10/22/antibiotic-resistant-superbugs-creating-deadly-risks-hip-knee/
"By the way, what exactly is a sachet? I do not think I ever took one."
Ever go to a lunch counter or diner and drink coffee with an artificial sweetener?
That little envelope containing the sweetener is called a (drumroll) sachet.
News tomorrow?
Or after close today?
Thanks for a great post!
Big Pharma's Strategy Is Music to Biotech Investors' Ears
Big Pharma bosses say they are willing to invest for the long run. That means high prices for promising biotech stocks aren't likely to fall any time soon.
WSJ. Sorry but link-less.
"I would say most every biotech startup mgt team would trade places with our team in a heartbeat, knowing that their chances for success would be about the best in the business."
The same logic says to shareholders: do not sell.
Yes the blog lives ... and that's very important.
I think the revamped site including the blog gives the staff people at BPs lots of material that could be used to prepare presentations to those at the top who would approve a major investment.
http://www.ipharminc.com/new-blog/2018/3/7/brilacidin-as-a-novel-late-stage-antibiotic-drug-candidate
PFE stock?
The "holy grail" of a cancer drug would be not a cure but a preventative, one that would ensure the consumers (of the pharmaceutical) that their chances of experiencing cancer are near-zero.
If daily consumption of the drug accomplished that what would be its value?
Billions of consumers x each taking pills daily = trillions of revenue.
(One can dream.)
Yes, overseas first makes sense.
It's a shorter path to acceptance, revenue and even profits.
"A leading international drug manufacturer has been engaged with to bulk produce commercial-quality Brilacidin, aimed at lowering patient drug cost and anticipating future drug needs in preparation for expedient market introduction. This critical step also proactively facilitates future patient and insurance reimbursement adoption through favorable cost savings ... "
This is (at least) as important as the CDA news.
IPIX can elect to emphasize foreign markets first, the USA later. Such a course could lead quickly to revenue and even, that favorite of all investors, earnings per share.
'I don't actually believe the blogs are designed to attract new money into IPIX.'
I think the redesign of the site, the name change and the "blog" postings, all of which are relatively recent, were aimed at prospective partners. They were not an attempt to attract new individual shareholders.
All BPs have staff people who prepare evaluations and proposals for top management. If I had that job I would like to find online useful stuff that could be quoted or paraphrased in a written proposal for my bosses.
There are always factors having nothing to do with the company whose stock is sold that influence or even cause people to sell, i.e., compelling needs for immediate cash.
On the other hand I cannot think of any reason why someone must buy stock immediately.
"Leo does like to send out fluff PRs no matter the criticism. It must be killing him to go thru a quiet period."
If major negotiations are underway the other party's lawyers may require silence.
(Just a thought.)
"Not even a fluff piece about the conference yesterday. A good sign."
Indeed.
Quiet is good.
" ... finally ‘on the line’ with what could be one fell swoop of the pen..."
I prefer George Gobels' version, "One swell foop."
"There are BP's interested in buying IPIX outright."
I would hope so.
Has Leo said as much?
Drug Industry Is Ripe for a Wave of Deals
Big pharma and biotech aren't benefiting as much from higher drug prices.
That raises the possibility of large deals.
https://www.wsj.com/articles/drug-industry-is-ripe-for-a-wave-of-deals-1515148200?mod=djemheard_t
Well done sir.
Or madam.
Merry Christmas.
Another company that "went foreign first" is AFLAC.
They sold cancer-death life insurance in Japan and much later (after making a ton of money) entered the US market for disability insurance (with those duck commercials).
Fact: more people live (and get ill) outside the USA than inside.
Another fact: FDA approval is slow and expensive.
A New Jersey medical company with European sales.
I am also a shareholder in Cytosorb which despite its American manufacturing and HQ location decided to sell in Europe and other international markets and postpone US entry.
IPIX could take the same path.
http://cytosorb-therapy.com/about/history/
Pfizer might prefer cash but stock for stock deals have tax benefits to the acquired shareholders. Leo and Menon might prefer stock.
I agree completely with what you wrote:
What you said is worth repeating:
Re B-OM Ph2 topline: A Lead-Off Stand-Up Double
(to use a baseball analogy)
Trial was a Success – Very Good results, imo, esp in the context that there are NO (repeat NO) effective OM treatments out there – let alone a placebo-controlled study that showed close to 30% ITT and 40% PP in PREVENTING OM, not just ameliorating symptoms. Ice chips analogy. Who wouldn't want to have a 30-40% of NOT getting OM. If I was taking chemotherapy, I'd say "Sign Me the Hell up!"
Also, note that 70% of drugs fail in Phase 2 so kudos to folks in Beverly, yet again.
The only other OM drug ever approved (Kepivance) was for Symptom Relief. B-OM is playing in an entirely different ballpark (that of Prevention), with few others (Enzychem) even targeting it as Primary. Soligenix had what a 7pt spread in Incidence and one arm actually did 7pts worse than placebo… and yet it is now in a Ph 3… with Duration/Onset the target endpoints.
Again, Context folks, Context.
Regarding BTD, how can folks say this is off the table? They haven’t even compiled all the data (Secondary/Exploratory) yet and the FDA has been throwing out FT to pretty much every OM company, like confetti, based on pre-clinical. One would think that the first drug showing true Prevention in humans would very much be in running for BTD. Go back and look at BTD criteria – language around providing a “substantial improvement” in care… and in OM, that is pretty much the lowest of bars… people are dying because of interruptions in care.
Also we are an oral-rinse, not IV – don’t discount this. In a yet untapped $1bn market where hundreds of thousands are suffering from chemoradiation side-effects.
Re dropout rate of 25% that is par for course in clinical trials. Can dig for the data if folks want, but it is what it is… esp w very sick OM patients, one might think it’d be higher.
The placebo response was a bit surp, 60% got SOM when lit shows closer to 70%... so in a larger Ph3 trial one would hope that our active-placebo spread would be even higher…. If we’d gotten closer to 30% reduction in incidence of SOM, I’d have characterized as a Home Run. Though will take a lead-off stand-up double any day.
Bottom-line: We’re standing on 2nd base with a chance to steal 3rd if we land a Partner and/or get BTD… and possibly on our way to crossing the plate as the first or one of the first -- esp in re to PREVENTION, not symptom-mitigation... though that is impt too -- OM drugs approved.
Game On.
"Brilacidin preventing severe oral mucositis is huge. Ph3 will likely tweak the dosing by improving delivery method or swish/spit more often."
Exactly.
The market was hoping for a blockbusting bomb but only got a hand grenade.
Next time, build a bigger bomb.
Rinse and spit involves minimal side effect risk since only a minuscule amount is ingested.
Has any other medication prevented a serious disease in any humans with only a "rinse and spit" procedure?