If you are having trouble viewing this message, please go to http://community.icontact.com/p/stockshaven/newsletters/distributionlistpublic/posts/optimer-short-opportunity-into-pdufa [1][2] Breaking News and Insider Scoops May 26, 2010 Optimer Looks Primed To Drop Going Into PDUFA Optimer looks ready to drop as labeling and script use will hamper the drug`s only advantange of already approved medicine Optimer Pharmaceuticals is quickly approaching its May 30th PDUFA as as heavy favourite to win a positive vote from the FDA to market its product, yet it seems that many investors are discounting the potential for a surprise negative outcome. The company is trying to obtain approval for its flagship product, fidaxomicin which could make it the first Clostridium defficile infection (CDI) treatment in more than 25 years. Currently, the infection only has two pharmacological options as treatments: metronidazole and oral vancomycin, both of which lack the ability to reduce recurrences, while improving global cure rates.

While the cure rates on fidaxomicin matched that of vancocin, the company has claimed that its real benefit lies in its ability to reducing the recurrence rate. In the two Phase 3 trials, among subjects who had experienced a prior CDI episode and recurred within three months of entering the study, treatment with fidaxomicin resulted in a 47% reduction in repeat CDI recurrence compared to Vancocin (p=0.045). The data also indicated that treatment with fidaxomicin significantly improved the recurrence rate and global cure rate in CDI patients requiring concomitant antibiotics compared to Vancocin. Fidaxomicin was well tolerated in both studies with no adverse side-effects ([3]See safety data here) and [4]safety data. Information courtesy of [5]Optimers fact sheet.

This hype has led to its stock gaining more than 40% within the last six months, helping its stock price rise from $9.50 to a new 52-week high of $14.20, yet despite the bubbly sentiment, serious problems are lurking beneath the surface. First and foremost is the fact that the products only advantage is its ability to reduce the risk of recurrence among CDI patients. On April, 4, 2011 the [6]FDA panel met to discuss a few issues and whether or not fidaxomicin was all its cracked up to be. Unlike many other previous panels, this one was fairly straight forward with only two questions to be answered.

First, Has the applicant demonstrated the safety and effectiveness of fidaxomicin for the requested indication, treatment of Clostridium difficile-associated diarrhea (CDAD) The panel, as expected with no surprises voted very highly on this with a 13-0 vote in favour of the drugs approval, leading to many singing praises thereafter, yet, there was one more question to be answered, albeit the most important as well.

Negative FDA Panel Outcome of Recurrence Benefit Perhaps the climax of the panels session was the answer to, Is the finding of lower recurrence of CDAD at Day 31 in the fidaxomicin-treated subjects of clinical significance An important thing to note, before even answering the question, some panel members were already discussing their interest in disregarding the recurrence data. The vote ended up being 6 yes, 7 no. Some of the comments for voting negatively on this question by the panel members were:

* Did not like recurrence endpoint because it was not a comparison of 2 randomized groups * Swayed by statistical arguments of relative weakness of recurrence analyses conducted by FDA, while also encouraged by the results of the 30 day resolution rate clearly favored with superiority fida.

* Given the study examined recurrence at 30 days, the information should be placed on the the label, a 30-day response should be in the label * One member stated that the design of the trial was not geared towards showing a recurrence benefit * Lastly, the data only addresses recurrence but not treatment of patients with CDI recurrence. The study did not specifically address or enroll patients who experienced CDI relapse.

Read the full report:

http://www.themarketfinancial.com/labeling-and-script-use-may-cause-problems-fo r-optimers-new-drug/126574 Latest Updates ___________________________________________________________________________ * $CYTK ex-US partnership approaching, could double * $OPTR should drop heavily on FDA decision * $DRYS looks for strong rebound as market recovers [7] [8]Disclaimer | [9]Terms of Use | [10]Contact Us | [11]About Us | [12]Become an Author |

CDAD · CYTK · DRYS · OPTR

If you are having trouble viewing this message, please go to http://community.icontact.com/p/stockshaven/newsletters/distributionlistpublic/posts/biotechs-expecting-corrections-into-asco [1][2] Breaking News and Insider Scoops May 15, 2011 Three Overvalued Biotechs Ready for Pullbacks Into ASCO Conference The month of May has thus far been a very profitable one for investors in a number of small cap biotechs leading up to the June 2011 ASCO meeting, particularly ones that havent consequently fared too well once their respective binary events had met its endpoints.

First up on the list is Oxigene, Inc. (NASDAQ:OXGN), whom has experienced nothing short of a meteoric rise from the $1.5 price per share level to the now $5.24 in a matter of three weeks following our report discussing their [3]nearing of marketing approval of the first anaplastic thyroid cancer drug.

While early technical analysis showed clear evidence of the oversold and undervalued condition, the stock has now begun trading at 10 times average volume in each of the past few days during this run, which often signals that a few hedge funds and institutions have begun to take a controlling stake in its low float, which sources list at 5.61 million.

While some argue that this could be due to a potential hostile takeover attempt, this is highly unlikely, and more so a elaborate scheme to control the price of the shares to their liking. More worrisome is the fact that fundamentals or significant changes to the outlook for the cancer drugs in its pipeline have nothing to do with the recent momentum, according to an [4]analyst at TheStreet. Investors are looking forward to the ASCO meeting which will provide updates for two studies in the companys flagship product, Zybrestat. Last September, researchers stated the companys drug (FACT study) had a median overall survival of 5.1 months compared to 4.1 months in ATC patients, one which was [5]not statistically significant by any means. This caused a spike in the share price from $5 to $8 in just a few hours which, in the end, resulted in a move back down and erasing all of the gains posted during that trading session.

The second set of results will come from the (FALCON study) for the companys advanced non-small cell lung cancer treatment, though it is not clear it will be ready for this years ASCO meeting. The last update in November showed patients treated with the drug had survival of 9.5 months compared to that of 8.8 months control arm, which was not statistically significant nor clinically meaningful. Again, despite bad results, the stock had a spike from $4 to $5.5 on the news, which would eventually come crashing back down to even par two months later.

Read the full report: [6]http://www.themarketfinancial.com/three-small-cap-biotechs-primed-fo r-corrections-following-asco/126461 Latest Updates ___________________________________________________________________________ * $OXGN, $SNSS, and $CYCC all expecting corrections into ASCO [7] [8]Disclaimer | [9]Terms of Use | [10]Contact Us | [11]About Us | [12]Become an Author |

ASCO · CYCC · OXGN · SNSS

If you are having trouble viewing this message, please go to http://community.icontact.com/p/stockshaven/newsletters/distributionlistpublic/posts/oxigene-asco-meeting-in-june [1][2] Breaking News and Insider Scoops April 20, 2011 Oxigene`s ASCO Meeting is on June 3rd, not May 18th * This article is up-to-date, our previous email contained an error in the date log * ASCO meeting is in fact, June 3rd to the 7th not May 18th With just a few weeks left on the calendar before the worlds largest oncology annual meeting, investors are already gearing up their portfolios for equities that could see exponential gains based on their potentially new research abstracts. The American Society of Clinical Oncology (ASCO) will begin on June 3rd and will feature everything from investigational new drugs to well developed late-stage products. While many companies have seen strong share appreciation leading up to their presentations, the real key lies in finding companies like Oxigene (NASDAQ:OXGN) which has yet to experience this momentum and mass media coverage.

At a market cap of only 10M, Oxigene remains the cheapest and most undervalued of all phase 3 late-stage oncology companies worldwide, with its flagship product, ZYBRESTAT targeting Tanaplastic Thyroid Cancer. The company has stated that they will be presenting the final phase 2/3 (FACT study) data for the drug at the ASCO, and many experts seem to be leaning towards highly positive results based on its previous clinical trials. Currently there exists no treatments available for this form of cancer other than radiation therapy and surgery which is usually combined with chemotherapy Read the full report:

[3]http://www.themarketfinancial.com/oxigene-nears-marketing-approval-of-first- anaplastic-thyroid-cancer-drug/126154 Latest Updates ___________________________________________________________________________ * $OXGN to present phase 3 data @ ASCO Conference, shares expected to rebound * $AEZS and $AVNR partnership rumours swirling on back of positive data [4] [5]Disclaimer | [6]Terms of Use | [7]Contact Us | [8]About Us | [9]Become an Author |

AEZS · ASCO · AVNR · OXGN

If you are having trouble viewing this message, please go to http://community.icontact.com/p/stockshaven/newsletters/distributionlistpublic/posts/oxigene-nears-cancer-fda-catalysts [1][2] Breaking News and Insider Scoops November 29, 2010 Oxigene Nears Marketing Approval Of First Ever Anaplastic Thyroid Cancer Drug (NASDAQ:OXGN) With just a few weeks left on the calendar before the worlds largest oncology annual meeting, investors are already gearing up their portfolios for equities that could see exponential gains based on their potentially new research abstracts. The American Society of Clinical Oncology (ASCO) will begin on May 18th and will feature everything from investigational new drugs to well developed late-stage products. While many companies have seen strong share appreciation leading up to their presentations, the real key lies in finding companies like Oxigene (NASDAQ:OXGN) which has yet to experience this momentum and mass media coverage.

At a market cap of only 10M, Oxigene remains the cheapest and most undervalued of all phase 3 late-stage oncology companies worldwide, with its flagship product, ZYBRESTAT targeting Tanaplastic Thyroid Cancer. The company has stated that they will be presenting the final phase 2/3 (FACT study) data for the drug at the ASCO, and many experts seem to be leaning towards highly positive results based on its previous clinical trials. Currently there exists no treatments available for this form of cancer other than radiation therapy and surgery which is usually combined with chemotherapy.

Just a few months ago, the company reported positive data from the FACT study of ZYBRESTAT plus chemotherapy in patients with Anaplastic thyroid cancer (ATC). At the 14th International Thyroid Congress, the companys investigators reported that patients receiving ZYBRESTAT had a median overall survival (OS) time of 5.1 months, compared with a median survival time of 4.1 months for patients receiving chemotherapy alone. Furthermore, 48% of patients treated with ZYBRESTAT and chemotherapy were alive at six months, compared with 37% percent of patients treated with only chemotherapy and at one year, 23% of patients treated with ZYBRESTAT and chemotherapy were alive compared to 9% of patients treated with chemotherapy alone. These are some of the best results of any late-stage Aanaplastic thyroid cancer drugs seen worldwide, and this improvement in OS is meaningful, both clinically and on a personal level for patients. With no currently approved drugs in the market for treatment, the doors are wide open for Oxigene to step in and dominate it. The company also reported on March 21st that they had [3]spoken with the FDA and received very positive type C meeting minutes stating that the trial data was highly suggestive of regulatory approval given an additional clinical trial with a suvival endpoint.

Read the full report: [4]http://www.themarketfinancial.com/oxigene-nears-marketing-approval-o f-first-anaplastic-thyroid-cancer-drug/126154 Latest Updates ___________________________________________________________________________ * $OXGN to present phase 3 data @ ASCO conference * $AEZS and $AVNR potential partnerships coming up [5] [6]Disclaimer | [7]Terms of Use | [8]Contact Us | [9]About Us | [10]Become an Author |

AEZS · ASCO · AVNR · OXGN

If you are having trouble viewing this message, please go to http://community.icontact.com/p/stockshaven/newsletters/distributionlistpublic/posts/buyout-rumours-for-optimer-pharma [1][2] Breaking News and Insider Scoops March 24, 2011 Optimer Pharma Buyout Rumours for $19 A Share Ahead of PDUFA Popularity in equities has never been higher than in 2011, with most analysts, including Hilary Kramer raving about the S&P 500 (NYSE:SPY) namely due to $2 trillion dollars worth of cash lying around on the balance sheets of companies.

This leads to mergers and acquisitions, along with consolidations which run up prices with the US treasury bond bubble which is deflating, leading to a flight to safety in equities. Despite Japans unfortunate natural disaster, the rest of the world economy has really begun to firm up thus alleviating fear and paving the way for one of the strongest bull markets in history to commence.

Such was the case with [3]AT&Ts shocking buyout of T-Mobile (NYSE:T), a marriage that cost $39 billion dollars, helping boost markets and confidence around the world. And while this deal received front-page acclamation on just about every mainstream media outlet, smaller companies have been engaging in such activities as well, especially the biotech industry. During February, Clinical Data (NASDAQ:CLDA) won a surprising approval for its flagship product, viibryd, the first antidepressant approved by the FDA in over 15 years, leading to Forest Labs (NYSE:FRX) sweeping in to [4]buy the company for $1.2 billion. Forests price reflects its interest in viibryds claim that it is safer and triggers fewer sexual side effects than other SSRI drugs now on the market. The drug is being touted as the first and only antidepressant to combine an SSRI and a serotonin 1a receptor partial agonist in one molecule.

This left many biotech bargain hunters looking for the next blockbuster buyout, which then leads to Optimer Pharmaceuticals. Much to the likes of Clinical Datas recently approved viibryd, Optimers flagship product, fidaxomicin, has a higher safety profile, along with many other added benefits which could make it the first Clostridium defficile infection (CDI) treatment in more than 25 years. Currently, the infection only has two pharmacological options as treatments: metronidazole and oral vancomycin, both of which lack the ability to reduce recurrences, while improving global cure rates. This is where fidaxomicin comes in it not only has a higher cure rate, but boasts a statistically significant reduction in recurrences and a substantially higher global cure rate. view the company CMO, Sherwood Gorbach [5]discussing its advantages in a video here.

Read the full report: [6]http://www.themarketfinancial.com/buyour-rumours-for-19-a-share-swir ling-around-optimer-pharma-ahead-of-pdufa/125740 Latest Updates ___________________________________________________________________________ * $OPTR placed on high buyout alert [7] [8]Disclaimer | [9]Terms of Use | [10]Contact Us | [11]About Us | [12]Become an Author |

CLDA · FRX · OPTR · SPY · SSRI · T