Linzess is often used to treat OIC. Phase Five has a decent track record in research.
Adynovate royalties at $15M/quarter = $60M/year. 5% royalty rate translates to $1.2B annual sales. Zero to $1.2B sales in one year, that would be one heck of a ramp!
Go to @vmlucey twitter.
PD-1 inhibitor + "your drug here" = The future of cancer treatment.
Unrespectable metastatic liposarcoma
Construction loans are very short term loans to fund home building. They are collateralized by the partly finished construction. These loans are 100% retained by SNFCA. They are both high profit and high risk. Most of the residential mortgage loans originated by SNFCA are packaged and sold into the secondary market.
The Company has entered into commitments to fund new residential construction loans. As of December 31, 2015, the Company's commitments were $61,067,000, for these loans of which $34,852,000 had been funded. The Company will advance funds once the work has been completed and an independent inspection is made. The maximum loan commitment ranges between 50% and 80% of appraised value. The Company receives fees from the borrowers and the interest rate is generally 2% to 6.75% over the bank prime rate (3.50% as of December 31, 2015). Maturities range between six and twelve months.
Let's talk historical trends. Do you recall that in the mid 2000's that foreclosures were often money makers for a bank? The value of the houses rose so rapidly that banks frequently recouped more than they were owed after foreclosing, fixing up, and subsequently selling. Which led to option ARM's, Tom Vu no money down ads, 125% LTV, history showed that you can't lose. People were making money hand over fist, until they weren't. Where are we today in the housing cycle?
Seconds and construction loans are the worst. Construction loans are about 30% of the total portfolio. SNFCA doesn't break out second mortgages in its SEC filings. In general, seconds lose 100% of their value before the primary mortgage loses one cent.
As of March 30, 2016, SNFCA is in a sweet spot. The most important historical trend related to SNFCA is that the company can crash and burn in a housing bust. By reinvesting all profit rather than returning money to shareholders in a cash dividend shows that management continues to double down on their mortgage strategy.
Seriously, if the housing market dies like it did in 2008, SNFCA is going to end up with a boatload of partially finished houses in half built neighborhoods. Worst case, recall the "ghost subdivisions"? The residual value of those loans (including maintenance, taxes, security, etc.) would be approximately zero.
SNFCA has $114M in mortgage loans, $5.4M of which are in foreclosure or over 90 days overdue. That's about 5% of the mortgage portfolio. Total reserves are $1.8M, about 1/3 of the non-performing value, about 1.5% of the total mortgage book. About 1/3 of the mortgage loans are high risk construction loans. SNFCA also mashes first and second mortgages in the 10-K. Anyone else find it unusual that SNFCA doesn't break out seconds/HELOC's in its asset listings? Hint... if the primary mortgage is impaired, the second is totally worthless.
BAC has $263.9B in mortgage loans, $8.1B of which are considered non-performing (over 90 days overdue). That's about 3% of the mortgage portfolio. Total reserves are $3.9B, about 1/2 of the non-performing loans, about 1.5% of the total mortgage book. These are primary mortgages only, seconds are broken out separately.
BAC is often called a basket case bank.
Page 61 of the 10-K says it all.
Only $100K reserve for $34M of construction loans. Yikes! Even today, $150K of construction loans are in foreclosure or greater than 90 days overdue. If the housing market freezes, insolvency will be staring the company squarely in the face.
PR is 5 3/4 paragraphs of sweetness and light, rainbows and unicorns. What the PR really says in the remaining 1/4 of a paragraph is that the planned major collaboration clinical study has been cancelled. Zero details on why that happened.
This PR is a classic example of management bamboozle.
Here are a couple of other things.
If one is going outside of North America and Europe for a substantial portion of the study one has to ask why? Is it because the drug is not interesting enough to investigators in Western Europe and North America? Is it the company is trying to do everything on the cheap? What’s the reason for that?
Just because the lead investigator is at some famous hospital I (Dr. Ratain) wouldn’t say that is a positive sign. It is not a negative sign. That is what you would expect, that they would be from at least some institution you have heard of, or that others have heard of, and that the investigator if you look him or her up at least has some track record in either drug development or the disease under study.
If you are looking to see if something is better than something we already know a lot about, then you need a really robust study. You’re looking for a large enough effect that somebody is going to say, “This is worth it, we would pay up for it compared to what the standard of care is”.
The article is a summary of a conversation AF had with Dr. Mark Ratain about interpreting PR's discussing clinical results. There is a full transcript on the Slingshot Insights web site.
Here are highlights.
Be very skeptical, however, of single-arm studies with progression-free survival or overall survival endpoints. Likewise, the use of an historical control is suspect.
If the headline of the press release states results are "positive," "outstanding" or uses some other superlative, assume there are problems hidden somewhere in the waning paragraphs until proven otherwise. Read the press release again.
Look for these re-assuring words/terms: Intent-to-treat analysis, statistical significance, achieved the primary endpoint. More details, more specific data are better than less.
Red flag words/terms to watch for: per protocol, retrospective analysis, responder analysis, subgroup(s), modified intent-to-treat, trend, grade five toxicity (that means a patient died.)
Were any changes made to the trial design, including endpoints? Did the company fully enroll the study as planned? Don't rely on the company to tell you. Compare the company's description of the trial with information listed on ClinicalTrials.gov. You'd be amazed how many times they don't match up.
Assuming the study was enrolled fully, can you track all the patients from beginning to end? I always pay attention to the "Ns" -- slang for the number of patients in each arm of the study. Look out for patients missing from analyses for inexplicable reasons. It's not unusual for patients to drop out of a study, but they still need to be accounted for in whatever efficacy analysis is being used. Patients "disappeared" are a red flag.
Too many companies spin failed trials with heaping shovels of bull****. I'm speaking, of course, of the classic data-mined subgroup analysis. Not every subgroup analysis is fraudulent.
-- "the bias toward euphoria in pain med trials may be real"
You are rationalizing failure before the Phase 3 results are in. Acetaminophen and the NSAID's reduce pain without the slightest hint of euphoria. So it's possible. NKTR-181 must not simply relieve pain. It must be more effective than these drugs to have success in the marketplace.
More importantly, Roche ACE-910 and Alnylam ALN-AT3 are working their way through clinical trials. These investigational drugs are subcutaneously (not intravenously) administered, and the anticipated dosing is once per month. If approved, these drugs will make existing hemophilia A treatments obsolete in a very short time.
"the largest decrease in LDL-C observed during treatment for each subject"... We cherry picked the very best result from each patient.
"no clear dose response was observed"... Results may be random.
"4 patients who showed a mean increase of 4%"... One third of the patients showed increased LDL-C.
"three treatment discontinuations for AEs"... One fourth of the patients couldn't even stay on the drug for three months.
"Positive results"... Management gets more bonuses and stock options. Hah!