Criptonite that sounds like a Trumpism.
So I should sell out are you saying? Just before the ASH build up? Why is Scarlet going Christmas shopping early?
the current SMA are setting up for a bullish run. 2 days out from the 20SMA crossing above the 200SMA. A few weeks away from the golden cross, opposite the death cross we saw in Sept when the SP dropped from $3.65 down to $2.60. We should regain our loss and then some. Charts don't lie, people do. The trend is your friend.
BP last year's ASH we had more submissions and within the 4 papers on AML, ET & MF presented via seminar, oral & abstract presentation format, none had significant impact on SP. ET & MF data wasn't even updated until the recent NEJOM publications. There were also no late breaking submissions as we had hoped for so I wouldn't expect "surprise" news this year again with less submitted early to discuss. Perhaps as you suggest & Scarlet implied the 1951 trial data data update may be the cattle list we may get but the 3 abstracts are on
#1.a subtype of myelodysplastic syndrome
#2.an analysis of mutations detected in ET patients treated with Imet
#3. evaluated the activity of imetelstat in a non-clinical model of AML.
Seeing as my cow has jumped over one too many barbed wire fences leaving udder disasters in it's wake, I'm remaining cautiously optimistic and not getting overly excited on ASH.
but what if I had 25 thumbs to vote with? There are many good questions that need addressing without being thumbed down. All people like magical thinking Irish_ Belieber and or Joko want are mindless munchkin land accolades. No self respecting investor can be happy with the SP today after such a promising new start in ASH 2013. Chippy has deliberately thrown out SP acquisition bumps to slow down any hope of SP acceleration. The SP started it's decline when that was brought up again in AUG's 8K. He is the CEO and the buck starts and stops there. With all the positive news SP should be at least $7.
well after I suggested that other company that starts with an M and ends with a Pee & EI EI O in btwn. it was like a piece of toilet paper stuck to my tail that followed me around on every board I posted. Funny thing was I made more off that than holding GERN for the last 2 years with only 10% of my capital. Getting out bfr their binary trial data event was key but the 1 month delay sounded warning bells after their PRD pumped it's prospects.
check OHRP rumor has it George Soros was buying it from under the Baker Bros. Played it once from $2-$15 but it's a nail biter and if you hold too long you could get whacked. Third times the charm.
got any stock tips? preferably a 10 banger fur this beaver. I hate watch'n wall paper peel off the ceiling. One day it'll be me or the paper that gotta go.
I appreciate your input Strawman and as your point out my knowledge & understanding of the science maybe simplistic but enough to pick up the scientific scent in order to follow by investing as I have. I read what i can and assumed the authors involved with the NEJOM had a much better take than me hence my questions.
Fast track designation is granted by the FDA to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designation confers some or all of the following benefits: more frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval, more frequent written correspondence from FDA about such things as the design of the proposed clinical trials and use of biomarkers, eligibility for accelerated approval and priority review, if relevant criteria are met, and rolling review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.
Orphan drug status is granted by the FDA to promote the development of promising therapeutics for the treatment of rare diseases affecting fewer than 200,000 people in the US annually. Orphan drug designation includes benefits such as a seven-year period of marketing exclusivity in the United States after approval. Other potential advantages come in the form of protocol assistance, the ability to apply for research funding, tax credits for certain research expenses, and fee waivers for the regulatory procedures
ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases trial 2015 Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in breast cancer patients with recurrent brain metastases. Orphan Drug status & Fast tracked May 2014
MENLO PARK, Calif., and MONTREAL, Canada December 6, 2010 - Geron Corporation (Nasdaq: GERN) today announced an agreement with Angiochem, Inc. for a worldwide exclusive license to peptide technology to facilitate the transfer of anti-cancer compounds across the blood-brain barrier (BBB) to enable the treatment of primary brain cancers and cancers that have metastasized to the brain. The license covers proprietary receptor-targeting peptides conjugated to tubulin disassembly inhibitors, including GRN1005 (formerly ANG1005), a novel taxane derivative, that has completed two Phase 1 clinical trials in patients with primary brain tumors and in patients with brain metastases from breast and lung cancer. In addition, the companies entered into a research and collaboration agreement to utilize these receptor-targeting peptides to transport telomerase inhibitors into the central nervous system (CNS).
"This in-licensing augments our oncology clinical pipeline to address metastatic brain cancer, a large global unmet medical need. In addition, the licensed technology will enable us to develop a telomerase inhibitor that penetrates the CNS," said Thomas B. Okarma, Ph.D., M.D. Geron's president and chief executive officer. "With GRN1005, we now have an additional compound tracked to provide Phase 2 human proof-of-concept in 2012. The results of the completed Phase 1 trial in brain metastases from common cancers showed that GRN1005 is highly active as a single agent. If these results are confirmed in our Phase 2 study, we anticipate rapid marketing approval. We also look forward to collaborating with Angiochem to combine the CNS-targeting peptide technology with our telomerase inhibitor technology to enable clinical delivery of its demonstrated preclinical activity against brain cancer stem cells."
I wouldn't trust my stock advice either....I've been stuck treading water & eating pellets here now for almost 2 years.
I'm a beaver that eats oval scat pellets that are 1 to 1 1/4 inches in length and 3/4 of an inch in diameter whilst treading water. When on shore I rub my bum all over logs and rocks and such, marking my territory with an oily castoreum secretion having a musky, vanilla-esque scent. There is much vulgarity to smelling vanilla but it makes my castor sacs sought after and prized by jerks like you.
not to quibble here Irish but ODD and expedited approval imply entirely different implications wrt approval & time frames. In the US and EU it is easier to gain marketing approval for an orphan drug, and there may be other financial incentives, such as extended exclusivity periods, all intended to encourage the development of drugs which might otherwise lack a sufficient profit motive due to limited demand.
.Priority Review; FDA’s goal is to take action on an application within 6 months(instead of 10) of applying
.Breakthrough Therapy; to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy
.Accelerated Approval; allowed drugs for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint.
.Fast Track; facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
The IMbark study trial which has already started for MF has been set up as a JAK comparative: a requirement for Breakthrough designation and or accelerated approval. Secondary endpoints will establish this. Once established eligibility for accelerated approval under Fast Track which can be initiated(requested) at any time during the drug development process, but typically, the fast track designation will occur during Phase 2 or 3 of the drug's clinical trials.( IMET's Emerge MDS trail)
There are some NDA time frame deadline restriction for some of these designations which may exclude from applying but as you can see the process becomes more complicated.