FDA Plays

[Guy]

TRLPF - Sold @.67 the shares i bought @.47-.48
as they are up 40% in 3 weeks.
Will hold the shares i bought @.61 & .67 through
the PDUFA date.

[Guy]

IPCI (3.67) - bought it here. FDA already approved their
generic Focalin a few months ago. This was their
first drug approved and they have a few more that
should be approved in the next few months, some of
them were filed approx 4 years ago so they are way due.

http://www.intellipharmaceutics.com/pipeline.cfm

[swampboots]

Guy saw this and said UMMM:

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=92579197&txt2find=gtxi

[Guy]

GTXI - bought @1.38. They are going to present
clinical data on Enobosarm in Breast Cancer at
ASCO 2014 on June 2nd and data to assess the primary
study endpoint expected in July.

From Q1 PR:
"Enobosarm 9mg, being studied for the targeted treatment of androgen receptor and estrogen receptor positive metastatic breast cancer: GTx is conducting a Phase 2, open label clinical study evaluating an oral daily dose of 9mg enobosarm for the treatment of androgen receptor (AR) positive and estrogen receptor (ER) positive metastatic breast cancer in women who have previously responded to hormonal therapy for the treatment of their advanced breast cancer. Nine clinical study sites in the US have fully enrolled the study with 22 postmenopausal women with advanced breast cancer to assess clinical benefit response after six months of enobosarm 9mg treatment, which is defined as either those women receiving treatment who have demonstrated a complete response (disappearance of all targeted lesions), a partial response (at least a 30 percent decrease in the sum of the diameters of the targeted lesions) or stable disease (no disease progression from baseline). Enobosarm 9mg continues to be well tolerated by patients in the study.

In preclinical and clinical studies, androgens suppress breast cancer growth. Prior studies have shown that women with metastatic breast cancer who have been previously treated with tamoxifen and whose cancer has progressed have responded to non-selective androgens, with overall response rates ranging from 20 to 60 percent. Although these non-selective androgens have been used to treat breast cancer, the unwanted virilizing side effects, including facial and body hair, enlargement of voice box, acne, and edema have limited their widespread clinical use. GTx believes that a selective androgen receptor modulator, like enobosarm, by targeting the androgen receptor in metastatic breast cancer, has the potential to provide clinical benefit to women with advanced breast cancer by treating their disease while minimizing the unwanted masculinizing side-effects associated with steroidal androgens. Furthermore, unlike steroidal androgens, enobosarm cannot be converted to an estrogen that could be detrimental in breast cancer.

The Company has determined that the study will meet the pre-specified goal of demonstrating at least three clinical benefit responses in a minimum of 14 patients with AR positive metastatic breast cancer. The study is ongoing and the last study patient is expected to have her primary endpoint visit in June of this year, with data to assess the primary study endpoint expected in July 2014. Preliminary data from the study is being presented at the American Society of Clinical Oncology (ASCO) in Chicago, Illinois on June 2, 2014, in a poster presentation entitled, “Enobosarm: A targeted therapy for metastatic, androgen receptor positive breast cancer.” The Company is planning to meet with key opinion leaders and other breast cancer specialists at ASCO to evaluate data then available from the study and discuss appropriate next steps for the development of this potential treatment option for women with advanced breast cancer."

SeekingAlpha article:

http://seekingalpha.com/article/2171763-pitt-hyde-and-mason-hawkins-buy-50-percent-stake-in-gtx-ahead-of-phase-ii-results

[kei]

PGNX $3.60 Progenics Pharmaceuticals Sets First Quarter 2014 Financial Results Call for May 9

http://finance.yahoo.com/news/progenics-pharmaceuticals-sets-first-quarter-113000792.html

[kei]

NAVB $1.60 Earning Announcement on May 7, 2014

http://finance.yahoo.com/q/ce?s=NAVB+Company+Events

[kei]

ASTM $4.20 Aastrom to Hold Annual Meeting of Shareholders on May 7, 2014

http://finance.yahoo.com/news/aastrom-hold-annual-meeting-shareholders-200500713.html

[Guy]

Added TRLPF @.47-.48 in the last
two days. Now averaged @.56
Way oversold here with PDUFA on May 28th.
On February, two of the largest shareholders
bought 14.8 million shares of TRL.TO @.71 ($10.5 million)
and it now trades @.52

Mentioned in an article about testosterone on the
Toronto Life: "In Canada, Eli Lilly is now producing an underarm supplement called Axiron, and Trimel will soon release a gel taken nasally. (Both, say the makers, reduce the risk of cross-contamination.)"

http://www.torontolife.com/style/toronto-health-and-beauty/2014/04/29/youth-in-a-bottle-synthetic-testosterone/

[Topgun21]

SYN HUGE BEWS OUT ON PERTUSSIS!!:)

Glta Tim
SYN

[Guy]

QRXPY adcom is today and POZN PDUFA on Friday. Not in these
two but good luck to anyone who is in.

[Guy]

TRLPF (.62) - "I like Trimel Pharmaceuticals (TSX:TRL), notwithstanding the selling pressure from its founding shareholder, because it has a better solution for the delivery of a topical treatment of low testosterone in men. The sleeper is that it has the same delivery system for women, where there is a major unmet medical need for female orgasmic disorder."

http://biotuesdays.com/2014/04/01/in-conversation-with-tony-pullen/

"Tony Pullen is one of the deans of Canadian capital markets. His career in biotech traces its roots to 1985 as an advisor to Cangene, which merged with Emergent BioSolutions (NYSE:EBS) in February. He also was instrumental in raising the initial capital for MDS Health Ventures, which went on to become MDS Capital Corp., formerly a leading biotech venture capital firm. In 1991, Mr. Pullen played a leading role in the formation of the biotech technology boutique within Yorkton Securities, which dominated a surge in sector financing until the early 2000s. After a restructuring of Yorkton, Mr. Pullen joined Paradigm Capital as a biotech investment banker and then subsequently left to work on his own with 15 to 20 relationship clients. He continues to work with his clients under the umbrella of D&D Securities. In this interview with BioTuesdays.com, Mr. Pullen reflects on the earlier contraction of the Canadian biotech sector, recent stirrings of a revival and companies with potential for success."

[Guy]

TBUFF (.64) - Up 9% today. Closed position and took
approx 60% profit on my last shares. This one
has been acting very strong during this Biotech
carnage. There was a seeking alpha article
out a few days ago:

http://seekingalpha.com/article/2134083-why-does-this-former-pharma-king-keep-buying-shares-of-tribute-pharmaceuticals

[Topgun21]

SYN Choo!! Choo!!

All Aboard!

GLTA!
Tim

[rickochey]

SYN. Took off late today. $2.55 as typed

[rickochey]

SYN had good volume yesterday and had a low of $2.17 and a high of 2.38 13 days until Ph II results on 4-28. Looking for an entry point.

[RealGenius]

ABIO S-3 filed for $75M.

[TycoonSoon]

I really like the consolidation pattern in the weekly chart for ABIO. I'll be looking to take an initial position probably this week and look to add if it can hold the 50sma.

[kei]

CMXI ONCS CTSO some otc bio are doing ok while most big board bio are in sell-off mode with IBB..

btw, i agree with you on SYN (zero shares currently)

[rickochey]

once the IBB stops bleeding, and according to TDAmeritrades charts SYN looks very darn bullish and the buyers might start to come back in. SYN has a Phase II update on 4-28. All reports show positive results.


Do your own DD.
all my posts are lies.

[kei]

CTSO green now ! looks like stopped bleeding whew!

[kei]

CTSO $0.21 CytoSorbents to Present at the 13th Annual Needham Healthcare Conference

https://finance.yahoo.com/news/cytosorbents-present-13th-annual-needham-123000303.html

[Norm]

Qrxpy 3.80 may jump on board tomorrow

[Guy]

ADMP (6.39) - I really like the potential
here. bought a month ago @6.3 #msg-97623052

New March presentation:
https://docs.google.com/file/d/0Bwgu6jYVrAKiaWFVUWZRdkx4OG1RNldudEY1cS16aE8xS3dj/edit

CRT capital research report:

https://docs.google.com/file/d/0Bwgu6jYVrAKiZDVfRWpPZ2E4b0hOc2p0LUZ5MlA4OFFxM0xj/edit?pli=1

[kei]

exploded! ASTM

[Bob Stocks]

Been eyeing this one for awhile...

[Bob Stocks]

TBUFF we had them do a presentation in our paltalk chatroom at the end of February....it was in the .30s then...what a move

[Guy]

QRXPY (4.13) - seekingalpha article out today:

http://seekingalpha.com/article/2102433-qrxpharma-pivotal-catalysts-present-significant-near-term-upside-potential?source=yahoo

[Guy]

QRXPY (3.94) - PDUFA date of 25 May 2014 for action on the Company's refiled New Drug Application for immediate release MOXDUO. The FDA will schedule an Advisory Committee meeting prior to this date (sometime in April).

http://qrxpharma.com/go.cfm?do=Page.View&pid=19

"Pending US approval, we are well prepared and poised to launch MOXDUO in the US with Actavis. Actavis' proven track record in the launching and marketing of opioid products will facilitate rapid uptake and significant sales in the US and maximize value for our shareholders."

"The FDA previously confirmed that the Company’s Combination Rule Trial, Study 008, satisfied efficacy requirements and that there were no efficacy or safety issues identified in any of the studies submitted in the original NDA"

http://qrxpharma.com/download/file/filings/2013/QRxPharma_Resubmits_MoxDuo_IR_NDA_Nov_2013_Final.pdf

March presentation:
http://qrxpharma.com/download/file/cp/QRxPharma_Investor_Deck_March_2014_Final_%2814_March_2014%29.pdf

[Guy]

TRLPF - bought more @.61. After the 1.5 million
block yesterday and Melnyk out of the way, i think the
bottom is in or almost in and the stock will be supported
around this level (the 200 day MA) and will bounce from here.

http://stockcharts.com/h-sc/ui?s=trl.to&p=D&yr=0&mn=9&dy=0&id=p05338879131

[basssque]

My FDA plays are ISR, CVM, ABIO, NAVB

[Guy]

TBUFF (.61) - up another 17% today and 56%
since my original post. Getting way overbought
here so sold some more.

[Guy]

TRLPF - the stock dropped because
Trimel's shareholder Eugene Melnyk has filed a notice of intention to sell two million shares, according to the Toronto Stock Exchange. As in the March 10, 2014, notice, Mr. Melnyk plans to sell the shares privately or through the TSX starting on March 17, 2014. Mr. Melnyk owns 39,110,783 Trimel shares.

Earlier today there was a cross of 1.5 million
shares @.65 and the stock is now up 5% to .74,
so i guess he is out of the way.

[Norm]

trlpf any idea why it dropped yesterday, tempted to pick up some more but difficult to find info. Im in at .70

http://www.trimelpharmaceuticals.com/Portals/0/IR%20-%20%20February%202014.pdf

[Guy]

TBUFF (.52) - up another 10% today and
30% since my original post. Getting a little
overbought here so sold some more today.

[Guy]

TBUFF (.47) - going up slowly in the last
few days with relatively big volume for this stock.
Sold some here.

[Guy]

OXGN was another good one. 160% in 2 weeks.
From $2 #msg-97962677 to $5.3 today #msg-98669854
Phase 2 results were out yesterday:
http://finance.yahoo.com/news/oxigene-announces-positive-topline-results-193553328.html
There are a lot of good opportunities with
biotech stocks.

[fredman]

WMGIZ is a great FDA play, imo. FDA Dispute Resolution Panel is likely better odds of approval of Augment as opposed to traditional FDA Appeal Process. Approval Milestone ($3.50) expires ~ 5 years, and that is a long time for things to materialize. The entire Company / Augment Department could be merged / sold off. Even without approval of Augment in US within 5 years, the revenue milestone payout(s) of $3.00 is a very likely outcome as Augment is being marketed in foreign markets. Please do your own due diligence and this is all in my own opinion. Good luck out there!

[Guy]

Re: NRIFF, i posted on it @1.7 #msg-94784723
and it tripled in 5 weeks #msg-96056362

[Norm]

I did we'll on nrif Canadian pdufa play. Will checkmout

[Guy]

TRLPF – bought @.67. They have a PDUFA on May 28th for
CompleoTRT , a testosterone replacement therapy.
They decided, following discussions with the FDA, to focus its CompleoTRT regulatory
submission on a three times a day and not twice a day dosing schedule.
This pushed the PDUFA date to May 28th (from February 28th).

Trimel also recently completed recruitment for the 240-patient, Tefina ambulatory Phase II study in
anorgasmia/female orgasmic disorder. Results should be out in Q214.

A few days ago they raised $10.5 million from current shareholders at market price:
http://finance.yahoo.com/news/trimel-announces-10-5-million-203753113.html

Trades in Canada as TRL.TO. 163 million OS shares.
Some of the people involved with TRL were also involved with Biovail (merged with Valeant and trades
as VRX on the NYSE).

February 2014 presentation:
http://www.trimelpharmaceuticals.com/Portals/0/IR%20-%20%20February%202014.pdf

[Norm]

Aezs shelf filing. 250,000,000. Not sure if its worth letting my capitlaln sit here now

[starbuxsux]

In Stunning Win For Open Science, Johnson & Johnson Decides To Release Its Clinical Trial Data To Researchers

Drug companies tend to be secretive, to say the least, about studies of their medicines. For years, negative trials would not even be published. Except for the U.S. Food and Drug Administration, nobody got to look at the raw information behind those studies. The medical data behind important drugs, devices, and other products was kept shrouded.

Today, Johnson & Johnson JNJ -1.33% is taking a major step toward changing that, not only for drugs like the blood thinner Xarelto or prostate cancer pill Zytiga but also for the artificial hips and knees made for its orthopedics division or even consumer products. “You want to know about Listerine trials? They’ll have it,” says Harlan Krumholz of Yale University, who is overseeing the group that will release the data to researchers.

“We really wanted a broad approach to contributing to advancing medical science through all of our products that touch patients in different ways,” says Joanne Waldstreicher, MD, Chief Medical Officer, Johnson & Johnson. “Responsible sharing of clinical trial data advances science and medicine and is part of Johnson & Johnson’s commitment to the doctors, nurses, patients, mothers, and fathers and all others who use our products,” said Paul Stoffels, MD, J&J’s chief scientific officer, in a prepared statement.

Here’s how the process will work: J&J has enlisted The Yale School of Medicine’s Open Data Access Project (YODA) to review requests from physicians to obtain data from J&J products. Initially, this will only include products from the drug division, but it will expand to include devices and consumer products. If YODA approves a request, raw, anonymized data will be provided to the physician. That includes not just the results of a study, but the results collected for each patient who volunteered for it with identifying information removed. That will allow researchers to re-analyze or combine that data in ways that would not have been previously possible.

Waldstreicher admits that there will be “a bit of a learning process.” What, for instance, about data from trials for rare diseases, where it may be possible to figure out who the participants were? Or what if the data is held not by J&J, but by a partner? But she commits to trying to get the data released even in those cases if it is feasible.

Krumholz, who heads the YODA Project, says that he hopes J&J’s leadership will set “a remarkable standard for data sharing that will ripple not only through industry but also through academia.” He hopes it will help the company by teaching them more about their drugs. “They’re going to get peoplelooking at their data for free.”

This is not the first time that a drug company has offered to make this type of raw, or patient-level, data public. GlaxoSmithKline GSK -2.29% has made big promises about doing something similar, although it is choosing its own review board to get data released. Medtronic MDT -1.28% worked on a similar project with YODA, but only for a single, controversial product, the bone drug INFUSE.

Scientists can make a request for data on J&J drugs by going to www.clinicaltrialstudytransparency.com.

http://health.einnews.com/article/188032375

[HEDMCRAIG]

Any thoughts on ASTM?

[Norm]

Aezs 1.28 May add if it drops more w/ the market on Monday.

[Norm]

Chtp if no delay by end next week watch this start to move. Still think there will be buying opportunity this week.

[jhnvtjll]

SNGX chart

[Norm]

Vnda pdufa date 1-31-14. Do not expect any great gains because approval may b factored in somewhat. Looking to enter low 13's tomorrow and sell high 15's on approval

[Norm]

Igxt- finally gonna break. .74 on to ifs run up to Feb Pfufa date .. will sell most of my shares b4 if not all.

[Norm]

Aezs. - good z to buy in and just let money sit for 9 months ..easy 3 bagger if u don't need the capital.

[Guy]

TBUFF (0.39) – Tribute Pharmaceuticals is an emerging Canadian specialty pharmaceutical company with a primary focus
on the acquisition, licensing, development and promotion of healthcare products in Canada.
Market Cap: $20M OS Shares: 51.0M

TBUFF has an experienced management team and board, which includes John Gregory who Founded and built King Pharmaceuticals (formerly NYSE:KG) which was sold to Pfizer for $3.6 billion. He is managing partner of SJ Strategic Investments, a family owned investment management firm. Mr. Gregory owns 16% of Tribute.
Robert Harris the President & CEO held executive positions at Biovail Corporation including VP of Business Development and GM of Biovail’s Canadian commercial group ,where he helped grow revenues to $150M within four years, leading to Biovail’s acquisition by Valeant (NYSE:VRX) for $3.2 billion. 20 years at Wyeth, now division of Pfizer (NYSE:PFE),where as Director of Sales of Specialty Care group he built out Canadian market segment.

Insider Ownership: 57%
Insiders bought in 2013 @.40 - .56:
http://finance.yahoo.com/q/it?s=TBUFF+Insider+Transactions

Tribute Pharmaceuticals Canada Inc.’s current portfolio of assets includes nine products: NeoVisc®, NeoVisc® Single Dose, Uracyst®, BladderChek®, Bezalip® SR, Soriatane®, Cambia®, Daraprim®, Collatamp G® and MycoVa™. Each of these products has received regulatory approval in Canada, with the exception of MycoVa.

TBUFF sells Cambia for acute migraine, in Canada. The medication is sold in a sachet form, a powder mixed with a couple of ounces of water. It is extremely fast acting. Nautilus Neurosciences has licensed Cambia to TBUFF.
A month ago, Depomed acquired Cambia US rights from Nautilus for $49 million:
http://finance.yahoo.com/news/depomed-acquires-cambia-diclofenac-potassium-210500674.html

http://finance.yahoo.com/news/cambia-r-tribute-pharmaceuticals-130000063.html

Another Tribute product is called Bezalip SR which is a fibrate drug intended to lower cholesterol. TBUFF acquired the license to sell the drug in Canada. The company also owns the license to sell Bezalip in the U.S.and filed an IND with the FDA in November:
http://finance.yahoo.com/news/tribute-pharmas-investigational-drug-application-130000337.html

Presentation:
http://content.stockpr.com/tributepharma/media/0a26f60f9fe2b220d091c62d6123d81e.pdf

This might be interesting here being so close to breaking above the 50 and 200 day MA @.39 & .42 respectively.