Good catch on SGYP, but more medium/long term are you bullish? Bit concerned if they don't get BO and/or have to raise money. NDA approval is far

SGYP. Odd timing to do this. Even if they are looking to raise money in the future, I guess they will do it after IBS-C results, or not?

TGTX You might be interested in this article if you have not come across it.
http://global.onclive.com/conference-coverage/hematology-2016/novel-btk-pi3k-inhibitors-on-horizon-for-relapsed-cll

More TGTX, RockRat,
With regard to the underdosing on their website you have several poster of phases 1 with design 3 + 3 to go by selecting the appropriate dose, it is a method rather than validated, with which you approach the effective dose while safe (all this does not mean that being a phase 1 chronic toxicities are not seen, nor the acumulatives or the rare). Completely agree is that is still very small and not comparable, so far it is effective but much safer, unwanted effects should come out later, but it is true that in idelalisib came before.

Regarding the comparative you do on the trials of idelalisib and 1202, would have to look at it, but a question, are you comparing same phases? I wonder why inclusion criteria are not available? in ClinicalTrials should be registered, I think it is mandatory, and finally you're comparing the same types of hematologic cancers?

SGYP -16.3% drops on increased volume in response to the company's filing of an 8-K today where it disclosed an exchange agreement with certain holders of its 7.50% Convertible Senior Notes due 2019. The company expects to issue 33.3M shares of stock in exchange for $79.7M aggregate principal amount of the debt plus $2.4M in accrued interest, implying a per-share price of $2.47. Yesterday's close was $3.40.

TGTX:
adding to my previous comment: Reading your good explanation, I assume you are not very optimistic in TGTX. Is that correct?
I don't know the motives of the shorts, but it is not a very exaggerated short number. At 29/02 were 8M of 54M shares outstanding, so 15% short, bearing in mind how the sector is going, does not seem an alarming figure. I would say they are in the average

These are some comments extracted form latest AF interview with GILD CSO
"We do feel some urgency and interest in acquiring something or doing a partnership but if we don't find one where we're convinced the science and commercial business case are solid then we won't do a deal."

Bischofberger also said Gilead has made a "very conscious decision" to steer away from investing heavily in popular but undifferentiated immuno-oncology targets like the PD-1 checkpoint inhibitors.

"Strategically, what we want to do, instead, is to ask the question: What is it about the 70% to 80% of people that don't have a response to anti-PD1 therapy," said Bischofberger. "We're absolutely very interested in immuno-oncology but only if it is a truly differentiated compound from what is on the market or in late-stage clinical studies."
__________________________________________
These is extracted from TGTX PR, taking advantage of latest GILD safety issues:
The recent announcement of the suspension of a number of studies of idelalisib due to toxicity concerns underscores the need for an improved PI3K-delta inhibitor that is not only efficacious, but safe, convenient and tolerable for patients. Many of the adverse events associated with existing PI3K-delta inhibitors such as colitis and hepatic toxicity, and most recently with opportunistic infections, are thought to be related to T-cell immune mediated mechanisms. To date, TGR-1202 has demonstrated what we and many investigators believe to be best-in-class safety and tolerability profile compared to existing PI3K-delta inhibitors. While still early, we are excited about the pre-clinical data that will be presented at AACR and believe it highlights key differences in the impact of PI3k-delta inhibitors on human T-cell subsets, which may begin to potentially explain the differentiated safety profile observed with TGR-1202 to date in the clinic. We look forward to the upcoming poster presentation by the team at Moffitt, and thank them for all their efforts in our ongoing research collaboration

the link you provided does not work.
Here you have the TGTX abstracts:
http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=d4f26745-ee36-42c0-9884-c9e6998a61b0&cKey=b1fe503a-4d5f-45f5-8f68-abad7cd72740&mKey=1d10d749-4b6a-4ab3-bcd4-f80fb1922267

I think they have inked a distribution deal with Valeant for Contrave

CNAT. I think you are correct and that is why it is 11% up after the call

I think it has been a great day for bios in general. See for example CPRX on no news closed +17,5%. Also CNAT +10% or ACHN +8% on no news either.

Sorry, I meant Amarin (not Biomarin).
Full disclosure, I am currently long ESPR as at these low prices, I believe it is worth the risk, I don't hold any other position in cardiovascular company at this point
Regarding EPA/DHA, I believe it is much better to take both, I agree 1g is low dose, but only EPA or only DHA is not the best choice IMO
- In one of the largest cardiovascular studies in Japanese, EPA add to your diet reduced their cardiovascular risk, but add not only DHA ( "Incremental effects of eicosapentaenoic acid on cardiovascular events in statin-treated Patients With coronary artery disease" Circulation J., 2009)

- Studies have found irrelevant supplementation of only DHA in pregnancy against postpartum depression and child neurodevelopment ( "Effect of DHA supplementation During Pregnancy on maternal depression and neurodevelopment of young children: a controlled randomized trial." JAMA, 2010) or Alzheimer's ( "Docosahexaenoic acid supplementation and cognitive decline in Alzheimer's disease: a randomized trial." JAMA, 2010).

As for the cardiovascular effects, I must point -we have to remember- that the primary responsibility for reducing inflammation is the EPA, not DHA. As for the neural effects, it is true that in the brain found significant levels of DHA, not EPA. In this regard, Dr Sears believes that although the EPA does a job so fast that hardly compared perceive their presence in brain mass, their work is crucial. Although the EPA hard days in the brain and DHA years, new EPA is responsible for specific antiinflammatory effects. And it would explain the superior results treating animal brain trauma with EPA and DHA ( "Omega-3 fatty acid supplementation and reduction of traumatic axonal injury in a rodent head injury model." J Neurosurg., 2011) that with just DHA ( " docosahexaenoic acid you reduce axonal injury in a traumatic head injury rodent model. "J Neurotrauma, 2010).

Therefore, when consuming Omega 3, it must be distilled or purified and not radically disparate amounts of EPA and DHA, but with a certain balance between the two. That s why In my family we supplement with EPA + DHA

I am still long TGTX, waiting for developments. I agree the price is ow at this point

Thank you Kiwi, Is Vacepa marketed in Europe? They both take EPA/DHA every day and mee too. i don't know if that could be similar to biomarin´s product. The EPA/DHA we take is:
EPA (ecosapentanoic acid) 720 mg + DHA (docosahexanoic acid) 480 mg

My perception is that GILD SOF/VEL approval will come before the ACHN/JNJ phase II update. They may be very close in time. sometime in June?

...and all this with their trials on track and no clinical trial failure. LOL

thanks DangerM. I bought it last week for my parents as they both have high colesterol (and are medicated with statins) they both consume Q10 and O3. My grandparents both from mother and father, died from atherosclerosis in aorta. So if this compound can in any way help, I will give a try. It is interesting to now that centella asiatica is used as a food, I didn't know that.
Basically Pycnogenol improves endothelial function and arterial blood flow and reduces oxidative stress and helps inhibit platelet aggregation
Centella asiatica has been shown in placebo-controlled studies to result in enhanced stability of arterial plaque, modulates production of collagen, which is found in the composition of the cap holding plaque in place. It also supports free radical defense mechanisms and helps promote healthy inflammation levels.

OT Atherosclerosis and Cardiovascular Disease
We have discussed about several supplements in the past. I would like to ask you, what are your thoughts on this supplement, aiming to protect against atherosclerosis.
Apparently the combination of 2 natural compounds (a combination of French maritime pine bark extract and Centellicum® Centella asiatica leaf extract)
prevents and protect against plaque progression and stabilizes the plaque to avoid breaks.
please, find below the article and looking forward to your comments.
article:
http://www.lifeextension.com/magazine/2016/2/slow-the-progression-of-atherosclerotic-plaque/page-01
supplement:
http://www.lifeextension.com/vitamins-supplements/item02004/arterial-protect

You say: "as is the fact that PTCT is offering no additional clarity on the nature of the omission"

IMO, they won't provide any explanation until they don't meet with FDA
Same for CPRX

RDUS up 30% on AMGN data
• Radius Health (NASDAQ:RDUS) is up 30% in reaction to Amgen's announcement of Phase 3 data for its osteoporosis candidate romosozumab that showed a 73% reduction in the risk of vertebral fracture in postmenopausal women.
• Radius' candidate, abaloparatide, showed an 83% reduction in vertebral fracture in its Phase 3 ACTIVE study. Its marketing application is currently under review in Europe. It expects to file its NDA in the U.S. in the near future.

Why you say short LABU in case of bearish on biotech? You can buy LABD which is the inverse ETF. Nevertheless Both ETFs are x3 so they have wild swings of + - 20% most days, so I would not recommend, you can get a heart attack! These ETFs are mainly for day trading IMO. Also I'm am not sure if liquidity is an issue. They are quite recent.

CPRX´s Firdapse is approved in Europe already. it is a matter of time it gets approved in USA too. There are a myriad of ways Catalyst can make the drug affordable for those who need it most.
Everybody knows Jacobus dont have a facility to produce any drug, they have a lot of complains from FDA, besides that they used a place which was to be nuclear plant facility before.
Jacobus has already acknowledged that they do not have the ability to file an NDA with the FDA.
They are a family owned compounding pharmacy which allows them to dispense the non FDA approved compounded formulation only with a patient's doctors prescription. CPRX has done all the necessary trials and has orphan and breakthrough status so there is no one going to jump the line.
Someone at Catalyst just didn't do the job they were hired to do.
CPRX Other RTF letter examples:
Acorda is another example of FDA refusal letter. Acorda received a RTF letter for the Fampridine-SR NDA on March 30, 2009, which cited the need to correct “format issues” and requested additional supporting information before the NDA could be accepted for review. Based on subsequent discussions with the FDA, Acorda resubmitted the Fampridine-SR NDA and all of the Agency’s comments related to the RTF were addressed.

By the way. CPRX most interesting compound is CP115, which early in the clinics.

CEMP 15% on no news either

but FDA decision for a RTF has nothing to do with their business model. I am trying to understand what is going on. FDA gives fast track and after a RTF?. Aren't they supposed to be working closely to fill the NDA properly?.

I buy Life Extension. They are good quality.

Something smells fishy. Valuation of CPRX lies in CP115 and Firdapse approval. I doubt they are that incompetent that they don't listen to FDA for a decent filing... As you know Jacobus is behind trying to file for similar compound at much cheaper price. May be in these days where is a debate everyday on drug pricing, they want politicians favour. I think it is really strange

Isn't it strange that that got fast track registration, which implies closer relationship with FDA team and after they get the refusal letter because FDA requests more information?

Actually it hit $251,8 but closed lower than that. I guess bottom is not in yet?

Yes you are right. IBB started well but is slightly red again. Lets hope it was not a dead cat bounce and that IBB can close at that $251.8 target.

ENTA is back today to $20. are you still adding? I remember you bought at that prices last october when the stock plunged on Vpack safety warning. Has the picture changed since October?

Do you mean there is no competitive difference between a 8/12 week cure vs a 6 week cure? IMO less drug for patients means cheaper drug regimen, which can induce doctors, governments and insurers to consider that therapy. Moreover, treatment adherence on antiviral agents starts to decline after 6 weeks. With shorter treatment periods needed, you provide greater likelihood that patients will complete the regimen, helping to ensure a favorable outcome.

Based on the public available data you can only guess, which is what I am doing.

ACHN/J&J HCV data this Q:
I guess, data could be released between today and March.
What are your expectations?
My bet is 100% SVR4 for 8 week and 6 week cohorts
what about SVR4 for the 4 week cohort?

thanks for sharing your thoughts

and for once, after the 20% rise onus, it didn't sell on news and hold the price.

on the basis that these are pure speculation "fiction" anything is possible ...

How Would that hypothetical J&J-GILD deal affect ACHN? Bearing in mind J&J/ACHN current HCV drug development

ENTA. Was going to ask you if you had an explanation, other than IBB reversal. Most bios green now but ENTA has hold pretty well in this down bio days.

Agree. I actually bought yesterday at $47

Magnesium threonate is a wide known and used compound. My parents take it for years and buy at LifeExtension. It is called Neuro Mag. see link: http://www.lifeextension.com/vitamins-supplements/item01603/neuro-mag-magnesium-l-threonate

What kind of medications are you thinking of that do the same job? From what I understand there is no current safe and effective therapy for posterior uveitis - apart from Medidur. And we are talking about a population of 75,000 U.S., 800,000 worldwide. Thanks for your input.