Additional incentives for the sponsor include tax credits related to qualified clinical trial expenses and a possible exemption from FDA application fees.
I would suggest checking out cytrx corp and their technology for treating different kinds of cancer. They too have over 100 mil in cash and no debt and real results with orphan designation for their drug called aldoxorubicin. Proves to be much more effective with no toxicity with 5X the does of dox alone. CYTR
This is what it means to have Orphan Drug Status:
The U.S. Food and Drug Administration (FDA) recognized the lack of incentive for pharmaceutical companies to develop cures for rare diseases and established the Office of Orphan Product Development. This branch of the FDA provides incentives to companies that work toward curing rare diseases by exercising the rights given to them under the Orphan Drug Act of January 1983. One type of incentive is the orphan drug status, which provides tax reductions and the exclusive right to develop the cure for a specific condition for a period of seven years to companies attempting to cure rare diseases.
Developing drugs to treat the vast number of diseases in the world is a line of business that can lead to massive fortunes, but unfortunately not all developed drugs become the golden ticket. In the world pharmaceuticals, the largest amount of money can be made by developing drugs that become the standard for curing common diseases.
From a business perspective, having a large market ensures that a company can quickly recuperate the cost of development and can also realize the largest possible gain. For this reason, there is little incentive for pharmaceutical companies to develop cures for rare diseases - those that affect fewer than 200,000 people in the United States - because the small market and high cost associated with finding these types of cures discourages these companies from entering this market.
It states Orphan Designation Status: Designated not only for treatment of glioblastoma multiforme but treatment of small cell lung cancer and ovarian cancer as well. However, it says FDA Orphan Approval Status: Not FDA Approved for Orphan indication. Not sure what this all means.
Do you mean linking aldox?
I doubled down as well at $3.41. Let's do this. My average is $4.12
Sant Chawla M.D. Director of the Sarcoma Oncology Center and Principal Investigator of the Phase III pivotol trial is very excited about it's ENORMOUS potential. Ever see the movie Armageddon? It's like a space ship landing on an asteroid (tumor) carrying a nuclear war head to blow it to hell.
The Overall Survival(OS) data from the Phase IIb first-line trail will be shared sometime in the second half of 2014. Well, that means you better be in this stock starting July 1st. It can come out any day from Tuesday until the end of December.
"We are hopeful that the next stage of development for aldoxorubicin, a well-tolerated single agent that lacks the cardiotoxicity associated with doxorubicin therapy, will demonstrate its potential to meaningfully extend survival, and will lead to a new treatment option for patients fighting this aggressive, life-threatening cancer."
A total of 123 patients with advanced soft tissue sarcomas were enrolled in the 31-centre Phase IIb trial and they were randomised 2:1 to receive either 350mg/m2 of aldoxorubicin or 75mg/m2 of doxorubicin every three weeks for up to six cycles.
These patients were then followed every six weeks with CT scans to monitor tumour size.
Two approaches were used to evaluate the efficacy of aldoxorubicin compared with doxorubicin in these patients, which include evaluation by the study investigators, as well as assessment by a blinded central laboratory review.
The trial's primary endpoint was PFS and secondary endpoints included PFS at six months for each group, ORR and overall survival, which will be reported when the clinical trial is complete.
CytRx president and chief executive officer Steven Kriegsman said these results were selected for presentation at the 2014 American Society for Clinical Oncology (ASCO) Annual Meeting.
"We look forward to discussing the data with the oncology community and to reporting the full overall survival results from this trial in the second half of 2014," Kriegsman said.
"In parallel, we continue to actively enroll patients in our pivotal global Phase III trial in second-line STS. In that Phase III clinical trial, we are permitted to dose until progression, which could substantially enhance the benefit for sarcoma patients."
Citi credit analyst James Finnerty initiated coverage on KB Home (NYSE: KBH) 4.75% 2019s with a Buy rating.
Finnerty said, "We believe KBH has upwards ratings momentum in the medium term given company guidance for improved profitability in 2014 which is expected to lead to the reversal of a large percentage of their Deferred Tax Allowance (DTA). We believe the resulting benefit to balance sheet leverage could be a potential positive rating catalyst."
He added, "KBH management is guiding for full year of profitability in 2014 which they expect will allow them to reverse a significant portion of their DTA of $844mm. The reversal would boost shareholders equity and therefore reduce debt/cap. At recent investor day guided to Net Debt/Cap ratio target of 40-50% by 2016 vs. 77% as of 1Q14 (57% adjusted for DTA reversal). At the time they also noted that ratings agencies were waiting for the reversal before incorporating the lower leverage into KBH’s ratings.
Homebuilding is picking up in Southern California after several slow years. Building permits were up 44% in the Los Angeles metro area in 2013, and have continued to climb this spring
The website still displays Come visit DigitalGlobe at GEOINT 2013! Please give us something current and we're not understanding the downhill decline in the share price.
KB Home is building off of the continued demand for housing in New Braunfels with a new community called West Village at Creekside.
Located along FM 1101, just east of Interstate Highway-35, West Village will join two existing neighborhoods the builder already has in this city just northeast of San Antonio — Caprock, located off of SH 46 and IH-35; and Legend Point, off of West Klein Road.
And it’s very possible that there will be more communities to come, according to Brett Dietz, who is the president of KB Home’s San Antonio division.
“We are aggressively searching for land in the San Antonio and New Braunfels area,” he says.
It’s not hard to understand why KB Home is targeting these two cities.
The San Antonio MSA, in general, has shown consistent improvement for several years now, explains Dietz, who points out that between year-end 2012 and year-end 2013, the number of new-home starts (number of homes builders commenced work on) was up 9 percent.
Over the same period of time, in New Braunfels specifically, new-home starts rose around 42 percent.
“ New Braunfels is the fastest growing submarket in the entire San Antonio MSA,” Dietz says.
And within this bustling community, much of the growth has been centered around the land that will soon be home to KB’s newest subdivision.
KB purchased the 120 acres for West Village about a month ago. The land is located right off of IH-35, Dietz says.
The community itself will feature amenities like a private swimming pool, walking trails and a children’s playscape. West Village will also be in proximity to three Comal Independent School District schools — an elementary, a middle and a high school.
The neighborhood will also benefit from its proximity to two wellness centers. Then there is the nearby retail mecca that is The Village at Creekside— which has proven to be a great consumer draw and a prime source of employment for many residents.
“We’ll have fantastic schools, great access and jobs — it’s a trifect
Can iron ore prices change quick or is it always a gradual move? Wondering what this can look like in a months time.