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BioRunUp / mikehavRx Merger: More Resources to Profit from FDA, Clinical Trial Binary Events

publication date: Oct 17, 2010
author/source: Mike Havrilla

We are extremely excited to announce the launch of an all new paid subscription service, which includes a merger with to include Mike Havrilla's premium content. We will also be presenting at the Third Annual PennyStocking Conference presented by Timothy Sykes on November 14-15 at the Mandalay Bay Resort and Casino in Las Vegas. All subscribers have been automatically rolled over into the new service with the same subscription terms...please contact us if you do not receive the merger notice with your new log-in information. is the best resource on the Internet for making consistent gains trading bio-pharmaceutical stocks. For those not familiar with the Run-Up method, here is the concept...Companies spend between $325-750 million from development to approval of a new drug as part of a process that takes about 8-10 years. This begins with the creation of the drug, followed by Phase I, II, and III clinical trials - all under the watchful eye of the FDA. Only at this point are some drugs assigned a date, at which approval or denial is to be announced. This decision date (PDUFA) is known at least 6 months in advance.

The Run-Up method involves locating and buying shares of these companies well before their decision date, riding the share price up, and selling BEFORE the FDA announces their decision. The concept can also be applied to clinical trials with data releases, but the goal is the same - minimize risk while maximizing profits and achieving this on a consistent basis.

However, not every FDA / Clinical catalyst event will result in a run-up.  When taking into account what stocks to discuss we take into account many factors, including (but not limited to) the following: market cap, potential market for drug / device / diagnostic in development, cash resources / potential for dilution or financing, market / analyst perception of FDA approval / trial success, partnership status, management reputation / track record, insider buying / selling, percentage institutional / fund ownership.

Research, Research, and more Research...By the time you hear about one of these stocks in the news it is too late. The best profits are made by getting in before the masses. This is what subscription service provides for you. We are constantly researching and using every resource available to find the next catalyst event. The FAQS page provides an overview of common abbreviations and terms associated with the drug development process, including clinical trials, the FDA approval process, and useful Web links / resources for additional information.

Currently, the following categories are offered to subscribers at Articles, Analyst Reports, BioRunUp's Trading Account, Catalyst Roadmap, Email Alerts Email, FDA Events Google Calendar Tracking, Members Only Forum, SMS Text Alerts, Valuation Studies, Weekly Newsletter, HavRx Healthcare Stock Indexes, mikehavRx Portfolio and Stock Watch List, Corporate Event Google Calendar Tracking for Bio-Catalyst Stocks, and the Clinical / Regulatory Bio-Catalyst Spreadsheet Tracking Database (which also includes an embedded table that is integrated with Google Docs / Finance).

Corporate Event Calendar for Bio-Catalyst Stocks...tracks presentations, quarterly earnings announcements, and other corporate events for all stocks included in the clinical / regulatory catalyst calendar database.

Clinical and Regulatory Bio-Catalyst Spreadsheet, Google Docs / Finance Tracking Database...tracks pending FDA / clinical trial binary events such as FDA decisions, FDA Advisory Panel meetings, clinical trial results / presentations, and pending FDA filings / clinical trials.

Mike Havrilla's ( trading stats) Portfolio Tracker / Watch List, Trading Account for BioRunUp ( trading stats)...The Bio-Catalyst, Rotating Run-Up Strategy is an active, flexible trading strategy with a targeted basket of 3-7 stocks with pending FDA or clinical trial catalyst events that seeks to rotate / position trade (i.e. sell gainers and buy or add to a position for catalyst stocks of interest with stock prices that are down or flat) based on market conditions and stock prices. The information flow includes the clinical / regulatory catalyst calendar database as the primary research source, which is refined to a top 10 stock watch list and 3-7 stock portfolio that is updated based on new developments and stock prices.

Subscribers receive premium access to BioRunUp's trading account / screen capture image and Mike's portfolio tracker auto-update widget - which also includes an updated top 10 stock watch list, screen capture image of his TD Ameritrade account, link to trading stats, and link to Mike's members-only forum thread that includes his stock trades / strategy. The members-only forum also provides threads for active FDA catalyst stocks, clinical trial event stocks, completed catalysts, and other topics.

The basket of 3-7 stocks is chosen approx. 2-3 months ahead of an FDA event (decision or advisory panel event) or clinical trial catalyst (preferably late-stage or pivotal studies) with a goal of achieving stock price gains and profits by selling ahead of the catalyst event. The exact timing of stock buys ahead of the catalyst date is not as important as screening for stocks that are preferably trading near or below the mid-point of their 52-week price range and at low or average trading volumes, which indicates that the stock is largely unnoticed by traders with the potential to experience increases in both share price and trading volume as the catalyst date nears.

Bio-Catalyst Roadmap...Seeks to identify stocks on a timely basis for potential run-up trades...for example, September Buys: Avanir Pharma (NASDAQ:AVNR) (10/30 PDUFA Date), Biodel (NASDAQ:BIOD) (10/30 PDUFA Date), Jazz Pharma (NASDAQ:JAZZ) (10/11 PDUFA Date), and EXACT Sciences (NASDAQ:EXAS) (10/29 Data Release). September Sells: Arena Pharma (NASDAQ:ARNA) (Pre FDA Advisory Panel Notes), Alkermes (NASDAQ:ALKS) (Pre FDA Advisory Panel Notes).

Email / SMS Text Alerts...Another benefit of being a subscriber is email and SMS text alerts of major announcements.  This system is not set to pump stocks but to pass on time sensitive critical information such as: FDA Approval / CRL (Complete Response Letter), FDA PDUFA action goal date extension / delays, FDA Panel Decisions, Dilution / Financing Announcements, Corporate Partnerships, and major insider buying / selling.

Detailed Valuation Studies and Bio-Analysis Reports...These valuation studies include extremely detailed information on FDA catalyst run-ups.  Using industry valuation models, we attempt to calculate the true run-up potential of a binary catalyst.

Weekly Newsletter / Watch List, e.g. 10/11/10...this week unofficially starts the long anticipated 'Super Bowl' of biotech catalysts.  This week alone we have FOUR FDA decisions...

HavRx Healthcare Stock Indexes: 10 passively managed, sub-sector healthcare indexes tracked by Google Docs / Finance, including stem cells / regenerative medicine, generic drugs, Health IT, health benefit providers, hospitals / facilities, emerging cancer diagnostic / therapeutic (Dx / Tx), immune therapy / vaccines, cosmetic / restorative medicine, diabetes care, and crop science.

These indexes can be used to identify potential plays within a sub-sector of healthcare stocks to identify potential acquisition targets in the rapidly consolidating generic drug or Health IT industries, undervalued stem cell / regenerative medicine companies, the next Dendreon (NASDAQ:DNDN) from the immune therapy / vaccines index, etc.