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and Remicade can have nasty side effects..."Some people using Remicade have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal."
maybe I'm reading too much into it....but it seems to me the FDA is almost guiding xxii to ask for stronger marketing language than "reduced exposure to nicotine".....perhaps something along the lines of "proven to reduce smoking" or "may reduce number of cigarettes smoked" or something along those lines that are backed up by all the studies NIH has paid for.
If that's the case the wait may be worth it.....
how come Chardan didn't mention China or current sales of XXII's products in Europe and US? 2 cent report or those things aren't worth talking about?
hey we could have a free spokesperson here.....i can see it now, Kardashian branded Purisol....
Only a government agency would take a year to decide "we need more info"
so does that mean you think the market is accurately predicting the next 12-18 months and readouts from multiple high potential clinical trials?
does the fact that the DMC is going to review efficacy necessarily mean they are going to publish the interim results on efficacy?
"Interim analysis after 36 subjects (18 per treatment group) by a Data Monitoring Committee (DMC); will review safety
and efficacy results"
reminds me of similar flies being attracted to the same piece of .....well you get the picture
If you find out where they're going next let me know so I can short the hell out of whatever mess they make next....
Interesting comparisons sox, though there are some significant differences. If Purisol can get good 2b results > 69%PASI then it should command leading market share in a $28.5 Billion/yr industry. I can't imagine BP wouldn't be willing to pony up a few billion if results are good.
1. Only 30% PASI at 700mg: "VTP-43742 demonstrated a clear signal of efficacy, with patients in the 350 mg dose group achieving a 24% reduction in the Psoriasis Area Severity Index (PASI) score relative to placebo. In the 700 mg dose group, patients achieved a 30% placebo-adjusted PASI score reduction."
2. Serious side affect with this one: "Wall Street gave Xenoport Inc. the hairy eyeball last September when data from the phase II trial hit the primary endpoint in psoriasis at both doses but turned up gastrointestinal (GI) side effects"
3. Very early, just finished a successful phase 1 trial: “Findings from this successful Phase 1 trial demonstrate that SNA-based drugs, such as AST-005, can regulate gene expression at the mRNA level in human skin."
4. Injectable, not oral but good results 69%PASI: "After nine months' treatment, 69% of moderate-to-severe plaque patients treated with the highest dose (180mg) of Boehringer's interleukin-23 inhibitor had clear or almost clear skin, compared to 30% of patients treated with J&J's Stelara (ustekinumab)"
Actually 2016 was less painful than 2015:
Jan 2, 2015 4.27
Dec 31, 2015 1.33 -69%
Dec 30, 2016 1.16 -13%
We all know that scumbag Rosen caused the big downdraft. I have complete confidence the successful progress on the science will eventually cause an inevitable 10,000% increase. Patience is a virtue....
So running more than one company into the ground isn't "with cause" for firing.....Cyrus biggest mistake from the beginning is betting their money on the wrong racehorse (or should I say donkey) to lead this pos
Makes me think Leo should take Purisol to market......"If Actelion were to go out at around $30 billion, this equates to around 13 times sales and 30 times earnings before interest and taxes. These are high figures."
Let me see we get Purisol to $2-3 Billion in sales by 2020ish and boom $30 Billion sale of Purisol anyone.....
The average cost for a phase 3 in dermatology is only $11.5 million. Fortunately dermatology is the lowest cost phase 3 trial of all therapeutic areas studied. Another of the lower cost phase 3 trials is gastrointestinal at $14.5 million. Seems to me CTIX could afford to do both with existing shelf. Max out the value Leo!!!
Wow over $28 Billion a year....maybe Purisol is worth $10 Billion....seems to me Pfizer might want a piece of this action....
"After decades of relatively unsuccessful treatment options, biologics came along to save the day with better efficacy. In the process, they’ve made billions of dollars for big pharma, with the likes of Humira by AbbVie (NYSE:ABBV), Remicade and Stelara by Johnson & Johnson (NYSE:JNJ) and Enbrel by Amgen (NYSE:AMGN) cumulatively generating about $28.5 billion in sales last year alone. While all those drugs are indicated for psoriasis, they also treat other diseases and conditions, such as forms of arthritis and Crohn’s."
I think you hit the nail on the head! Unfortunately I'm not sure a Trump govt helps our case. Here's hoping the FDA does the right thing!
I must say I'm a little surprised BP hasn't partnered with them yet (or bought them out). Seems like it'd. E a relatively affordable proposition at this point......
Wouldn't a guy with these credentials, and a member of the CTIX scientific advisory board, be able to source some grant funding?
"Dr. Sonis also is a Founder and Chief Scientific Officer of Biomodels, LLC, a preclinical contract research organization that evaluates novel drugs for pharmaceutical and biotechnology companies. Widely respected by his professional peers, he is the author of over 250 original publications, reviews and chapters, 11 books, and 5 patents, serves on a number of editorial boards, and is a founding member of the International Society of Oral Oncology and the International Academy of Oral Oncology."
I sure hope B-OM motors along quickly....looks like Dr. Sonis's other project at SGNX is a little further ahead announcing positive phase 2 results.
http://www.soligenix.com/news/soligenix-announces-investor-webcast-event-origins-innate-defense-regulators-review-sgx942-phase-2-study-results-oral-mucositis/
Maybe Dr.Sonix can help us get some grants for a CTIX run phase 3??
"The Phase 2 oral mucositis clinical study was partially funded with a grant from the National Institute of Dental and Craniofacial Research Small Business Innovation Research grant #1R43 DE024032-01 (Soligenix, Inc)."
Shouldn`t Purisol be premium priced if it`s safer and the positive effects last longer than the bilologics...... :)
Sounds like Taltz has some nasty side effects:
For Healthcare Professionals
Applies to ixekizumab: subcutaneous solution
Dermatologic
Common (1% to 10%): Urticaria
Uncommon (0.1% to 1%): Angioedema[Ref]
Gastrointestinal
Common (1% to 10%): Nausea
Uncommon (0.1% to 1%): Oral candidiasis, inflammatory bowel disease[Ref]
Hematologic
Very common (10% or more): Neutropenia (11%)
Common (1% to 10%): Thrombocytopenia[Ref]
Immunologic
Very common (10% or more): Infections (26%), immunogenicity (22%)
Common (1% to 10%): Tinea infections, influenza
Uncommon (0.1% to 1%): Serious infections[Ref]
Local
Very common (10% or more): Injection site reactions (17%), erythema, pain[Ref]
Ocular
Common (1% to 10%): Conjunctivitis[Ref]
Respiratory
Very common (10% or more): Upper respiratory tract infections (including nasopharyngitis and rhinovirus infection) (14%)
Uncommon (0.1% to 1%): Rhinitis[Ref]
References
1. "Product Information. Taltz Autoinjector (ixekizumab)." Eli Lilly and Company, Indianapolis, IN.
I wouldn't be surprised if B-UP and K-Ovarian aren't very close behind for two more Phase 3s!!!!
It's also interesting to note that prior to implosion today, DPRX had a market cap bigger than what CTIX has now....and they only had one potential drug for diabetic foot ulsers....WOW. CTIX has so much more potential with three potential multi-billion dollar platforms. Comparing CTIX to other small bios kind of puts things in perspective for me. It's just a matter of time until partnership and big gains!!
Wow it's good to know that CTIX isn't a one hit wonder like DPRX. If we ever do fail a clinical trial we won't go down 80% like they did.
Add another zero to your $250 million for B (and I'm just suggesting one indication...B-OM perhaps) then you might be in the neighborhood of what CTIX should get in an all cash deal, see comparisons here: http://s.wsj.net/public/resources/images/BN-PQ865_BMOBio_P_20160901133845.jpg
Flash what page is that quote on?
This is my favorite line in Sullivan's filing..."The reasonable attorney’s fees at issue here do not even begin to compensate the Defendants for the harm caused by the decision to file a class action lawsuit based purely on a story on the internet by an anonymous author who, in all likelihood, was involved in securities fraud." Nail him to the wall!!!
Wow over 3 billion in the quarter for Pfizers psoriasis drug!?!?
Taltz is poised to challenge etanercept, made by Pfizer and marketed as Enbrel. The drug, sold outside the U.S., brought in $3.33 billion in Pfizer’s fourth quarter, down 13% from a year earlier and representing 7.5% of total sales.
I like the suggestion of governments offering a prize for new antibiotics developed!!! Maybe it could be along the lines of the voucher program
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm
Who has Henry's email? Would like to see him on this FDA Advisory Committee
Request for Nominations of Voting Members of the Tobacco Products Scientific Advisory Committee - FDA’s Center for Tobacco Products (CTP) is requesting nominations for voting members to serve on the Tobacco Products Scientific Advisory Committee (TPSAC). TPSAC advises the FDA in its responsibilities related to the regulation of tobacco products. The Committee reviews and evaluates safety, dependence, and health issues relating to tobacco products and provides appropriate advice, information, and recommendations. Voting members are knowledgeable in the fields of medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products.
https://www.federalregister.gov/documents/2016/09/12/2016-21819/request-for-nominations-for-voting-members-on-a-public-advisory-committee-tobacco-products?source=govdelivery&utm_medium=email&utm_source=govdelivery
CTIX in some good company here. Mentioned in Bile Duct Cancer research.
http://finance.yahoo.com/news/world-bile-duct-cancer-cholangiocarcinoma-150500717.html
It boggles my mind how the author of the BS SA article can remain anonymous. I find it tough to reconcile that anyone can fabricate any kind of story and publish it with the sole intent of making money and harming others and the justice system condones this and protects the guilty??? At what point does common sense come into play in the legal system? I guess Seeking (aholes) Alpha ensures never.
72% of doctors in Canada say "buy XXII"....oops I meant to say "regulate amount of THC in Cannabis"....same thing right.....
https://www.thestar.com/news/canada/2016/08/24/doctors-want-feds-to-regulate-thc-levels-in-recreational-marijuana-survey.html
When the government nanny state mandates your product how can you lose....
Interesting chart on acquisition timing....
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=124665373
I really like the results....and the last line of the report
"Funding:National Institutes of Health (NIAID)"
Wow over six years from start of phase 2 to approval......good job they didn't have to go to a phase 3. I hope its much shorter for K study.
https://clinicaltrials.gov/show/NCT01078662
I would have thought being President of a dermatology and hair transplantation company for 11 years he'd have more hair.....
Barron would you mind reposting the instructions?
Sounds like another terrific move by Valeant..........getting approval for a dangerous drug other BPs ran away from.....
[url][/url][tag]https://www.psoriasis.org/advance/psoriasis-trial-drug-halted-due-to-suicide-concerns[/tag]
Psoriasis trial drug halted due to suicide concerns
Development of brodalumab halted based on reports of suicidal thoughts and behavior during clinical trials for the drug,
01/05/16 |
According to a statement released last week, one of the makers of brodalumab, a biologic drug currently being tested as a treatment for psoriasis and psoriatic arthritis, will no longer participate in developing the drug. Amgen, which, along with the company AstraZeneca, had been developing brodalumab, has stopped developing the drug based on reports of suicidal thoughts and behavior during clinical trials for the drug, the company stated in a press release.