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With so much biotech information located on one site, we felt it would be wise to create a basic user's guide to ensure our subscriber's get the most from BioRunUp.com--read each item carefully and follow the steps to take full advantage of all we offer. In addition, below the user's guide are biotech stock research tools & websites along with a summary of key regulatory and clinical trial catalyst terms & timelines.
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Read about us through our "About Us" webpage (link), as well as following us on Twitter:
Mark Messier: @BioRunUp
Mike Havrilla: @MikeHavrilla
Steve Johannson: @SteveJo22
Rich Underbrink (Skipy): @SkipJackRick
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FDA / Clinical Events Calendar
One of the original features of BioRunUp.com is the FDA / Clinical Catalyst Calendar. To learn more about an item, click on the event on the calendar.
Most of the events on the calendar are FDA related, as it is not often that a clinical catalyst has a specified and concrete date, although this is possible.
Click HERE to view the calendar.
Watch Past Webinars
We host live webinars twice monthly, and all webinars are recorded and available for on-demand viewing by subscribers. Click HERE to view.
One of the best ways to stay ahead of the curve is to scan over the bio-catalyst spreadsheet DAILY. This spreadsheet is where most of our trades originate from with daily updates to this database, which is often the basis for our articles. Find the next catalyst before the masses and make large percentage gains. Click HERE to view the database with sortable columns to identify the most near-term catalysts, lowest price companies, etc. & ability to download the spreadsheet file.
The BIO360° Heat Map tracks all of the stocks from our catalyst database with a default display that sorts the tickers by percentage daily change from biggest gainers (green) to losers (red). Additional tabs are included to quickly sort the catalyst database tickers by company name, most near-term catalyst dates, price (low to high), daily trading volume (high to low) and market cap (low to high). Within each of these sort options; the stock tickers link to an all-in-one research spreadsheet with multiple tabs that display an auto-update summary of key financial metrics, upcoming catalysts, major shareholders, news, SEC filings and historical price data to provide a full-circle solution for conducting stock research quickly and efficiently.
The Reg/Med Meeting Tracker includes tabs along the bottom to track upcoming catalysts at regulatory and medical meetings throughout the year with imported data from our catalyst database, links for meeting info/abstracts and links to our all-in-one research reports for each company.
View our Trading Accounts
Spreadsheets are updated once daily during trading days in which trades are made. For detailed explanations of each trade and multiple updates throughout the trading day, visit the forums. For Mark's click HERE. For Mike's account click HERE. For Steve's account click HERE.
- Twitter is a major resource for biotech stock news, interacting with other traders, monitoring news flow & trending stocks
- www.NASDAQ.com: Free real-time SEC filings, short interest, ownership summaries, information on recent / pending initial public offerings (IPOs) and more
- Yahoo Finance (http://finance.yahoo.com): Good for tracking key stats, monitoring news/blog headlines, options trading, analyst coverage and for tracking multiple stocks in portfolios. Keep in mind the financial stats provided by third-party providers such as Yahoo, Google, etc. may not always be accurate or current with SEC filings serving as the most accurate & current source for this information.
- Broker-Specific Resources: Ability to research company fundamentals, SEC filings, short interest, options, create watch list to monitor news headlines & track price movements, analyst coverage, etc.
- www.SeekingAlpha.com: aside from the opinion articles at the site; SA offers very useful transcripts for quarterly results, presentations, etc. posted shortly after the events take place
- Company Websites: many offer free email updates (typically available in the investor relations section) for notification of new SEC filings, news events, presentations, and other corporate updates that are useful for timely information that might otherwise be missed or noticed after the fact
- Federal Register (FDA) (www.federalregister.gov/agencies/food-and-drug-administration): useful for advanced notice of pending FDA advisory panel meetings & offers free email updates
- FDA resources include email updates and news feeds from the Agency related to new drug approvals and advisory panel meetings…
New Drug Applications (NDA): The new drug approval process generally involves (1) the completion of preclinical laboratory and animal testing in compliance with the FDA's GLP regulations; (2) submission to the FDA of an Investigational New Drug (IND) application for human clinical testing that must become effective before human clinical trials may begin; (3) performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed drug product for each intended use; (4) the satisfactory completion of an FDA pre-approval inspection of the facility or facilities at which the product is produced to assess compliance with the FDA's cGMP regulations; and (5) the submission to and approval by the FDA of a NDA (drugs) or BLA (biological agents).
The NDA also must contain extensive manufacturing information, and the FDA may approve or disapprove the NDA if applicable regulatory criteria are not satisfied or it may require additional clinical data (i.e. a complete response letter or CRL). Once approved, the FDA may withdraw the product approval if compliance with pre- and post-market regulatory standards is not maintained or if problems occur or are identified after the product reaches the marketplace. In addition, the FDA may require post-marketing studies to monitor the effect of approved products and may limit further marketing of the product based on the results of these post-marketing studies.
The Prescription Drug User Fee Act (PDUFA) of 1992 is legislation (PDUFA V is the most recent version of this law that is in effect from 10/1/12 to 9/30/17) that allowed FDA to collect fees associated with new drug and biological agent filings.
The PDUFA decision goal date is a performance metric that places a timeline on different types of submissions to the FDA & the timelines include 8 months for priority review & 12 months for standard review of new molecular entity NDA/BLA filings; 6 months for priority review & 10 months for standard review of non-NME NDAs such as new formulations of previously approved drugs through the 505(b)(2) NDA pathway; 6 months for priority review & 10 months for standard review of efficacy supplements (e.g. sNDA/sBLA filings); and either a 2-month (Class 1) or 6-month (Class 2) review for NDA/BLA resubmissions in response to a CRL.
New Molecular Entity (NME) / New Chemical Entity (NCE): a drug that contains no active component that has been previously approved by FDA.
FDA Advisory Committee (Ad-Com) Meetings: the FDA has dozens of committees and panels to obtain independent expert advice on scientific, technical, and policy matters -- including input during the review of new drug, biological agent, and medical device / diagnostic product candidates to obtain a vote on safety and effectiveness and if the available data is sufficient to support FDA approval; the FDA is not bound to follow the recommendation of advisory panel meetings, but typically does go along with the recommendations--especially in cases where the vote is strongly in favor or against approval.
Complete Response Letter (CRL): formal FDA notification that indicates a new drug or biological agent review period is complete and that the application (e.g. NDA, BLA, sNDA, sBLA) is not ready for approval & which outlines the specific concerns or deficiencies for not approving the new drug or biological agent. Chemistry, Manufacturing, and Controls (CMC) issues are often cited in CRLs and include non-clinical information on the manufacturing, product stability / shelf life, and quality control of the manufacturing process as assessed by FDA inspections and non-clinical data / testing.
Click on the table below or "PDUFA V" for a link to the full document on the FDA website. The FDA typically responds within 60 days to accept a NDA/BLA or sNDA/sBLA for filing and the Day 74 letter typically includes the PDUFA decision goal date and notifies the sponsor whether an advisory panel meeting will be conducted during the review. For a NDA/BLA resubmission; the FDA typically replies within 14 days to notify the sponsor whether the filing is accepted as either a two-month Class I resubmission or a six-month Class II resubmission.
Supplemental NDAs or BLAs are filed to obtain FDA marketing clearance for a new use, strength, or formulation of an already approved drug or biological agent, and the Agency typically responds within two months to formally accept for review and issue a PDUFA goal action date for all new drug or biological agent filings.
Abbreviated New Drug Applications (ANDAs): An ANDA is similar to an NDA except that the FDA generally waives the requirement of complete clinical studies of safety and efficacy. However, it may require bioavailability and bioequivalence studies. Bioavailability indicates the rate of absorption and levels of concentration of a drug in the bloodstream needed to produce a therapeutic effect. Bioequivalence compares one drug product with another and indicates if the rate of absorption and the levels of concentration of a generic drug in the body are within prescribed statistical limits to those of a previously approved drug.
Under the Hatch-Waxman Act, an ANDA may be submitted for a drug on the basis that it is the equivalent of an approved drug regardless of when such other drug was approved. The FDA will approve the generic product as suitable for an ANDA application if it finds that the generic product does not raise new questions of safety and effectiveness as compared to the innovator product. An ANDA filer must certify one of the following... (1) that no patent was filed for the listed drug (a "paragraph I" certification), (2) that the patent has expired (a "paragraph II" certification), (3) that the patent will expire on a specified date and the ANDA filer will not market the drug until that date (a "paragraph III" certification), or (4) that the patent is invalid or would not be infringed by the manufacture, use, or sale of the new drug (a "paragraph IV" certification). A paragraph IV certification (patent challenge) must be provided to each owner of the patent that is the subject of the certification and to the holder of the approved ANDA to which the ANDA refers. A paragraph IV certification can trigger an automatic 30 month stay of the ANDA if the innovator company files a claim which would delay the approval of the generic company's ANDA.
Section 505(b)(2) NDAs: For a drug that is identical to a drug first approved after 1962 (e.g. a new formulation of an existing drug that may be an extended-release or delivered in a novel manner), a prospective manufacturer is not required to go through the full NDA procedure. Instead, it may demonstrate safety and efficacy by relying on published literature and reports where at least some of information required for approval comes from studies not conducted by the applicant, thereby reducing the time and money required for potential approval through this route.
Click HERE or on the table below for a summary document of FDA programs for expedited review.
Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within 60 days based on whether the drug fills an unmet medical need in a serious condition. Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.
Breakthrough Therapy Designation (BTD) is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). BTD is requested by the drug company. If a sponsor has not requested BTD, FDA may suggest that the sponsor consider submitting a request. Ideally, a BTD request should be received by FDA no later than the end-of-phase-2 meetings if any of the features of the designation are to be obtained. Because the primary intent of BTD is to develop evidence needed to support approval as efficiently as possible, FDA does not anticipate that BTD requests will be made after the submission of an original BLA or NDA or a supplement. FDA will respond to BTD requests within 60 days of receipt of the request.
Accelerated Approval (AA): When studying a new drug, it can sometimes take many years to learn whether a drug actually provides a real effect on how a patient survives, feels, or functions. A positive therapeutic effect that is clinically meaningful in the context of a given disease is known as “clinical benefit”. Mindful of the fact that it may take an extended period of time to measure a drug’s intended clinical benefit, in 1992 FDA instituted the Accelerated Approval regulations. These regulations allowed drugs for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint. This process often applies to cancer drugs whereby AA may be granted based upon Phase 2 results on the condition that the sponsor conducts additional Phase 3 clinical trials to obtain full approval.
The Orphan Drug Designation (ODD) program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug. The ODD program is designed to provide economic incentives (e.g. seven-year market exclusivity in the US & 10-year marketing exclusivity in Europe from approval, R&D tax credits, waive of PDUFA filing fees) to drug developers to treat conditions affecting a small number of people which otherwise might be neglected. The FDA seeks to review ODD applications within 90 days.
Qualified Infectious Disease Product (QIDP): QIDP is a designation for antibiotic drugs created through 2012 GAIN (Generating Antibiotic Incentives Now) legislation to encourage the development of treatments for drug-resistant organisms known to cause serious or life-threatening infections such as MRSA (methicillin resistant Staphylococcus aureus). The QIDP designation includes priority review, Fast Track eligibility and a five-year extension of marketing exclusivity upon FDA approval--resulting in 10 years of marketing exclusivity from the time of FDA approval by adding to the five-year exclusivity granted for new chemical entity (NCE) approvals.
Medical Devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval (PMA). Medical Device User Fee Amendments of 2012 (MDUFA III) is the legislation regulating medical devices in the US.
Products requiring PMAs are Class III devices, classified as high risk devices that pose a significant risk of illness / injury or those found not substantially equivalent to Class I and II predicate devices already cleared for marketing through the 510(k) process. The PMA process is more involved and includes the submission of clinical data to support claims made for the device. The review timelines for PMAs include: 45 days to accept filing for review, Day 100 meeting (advisory panel meeting may be scheduled), and a final decision that typically follows within weeks-months of the advisory panel meeting with an average review time of slighlty more than one year for PMAs based on performance tracking stats.
A 510(k) is a submission made to FDA prior to marketing in order to demonstrate that the device is at least as safe and effective (substantially equivalent) to a legally marketed device that is not subject to PMA. For a successful FDA 510(k) submission, the medical device company must compare their device to one or more similar legally marketed devices in order to support the claim of being substantially equivalent to a device already cleared for marketing by the FDA (predicate device). The review timelines for 510(k)s includes: 15 days to accept filing for review, substatnial interaction within 60 days and potential for final review within 90 days although the actual average time to a decision based on performance tracking metrics is 4-5 months, which can be prolonged if additional information is requested during the review process.
The Humanitarian Use Device (HUD) program designates a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals in the US per year. This is very similar to ODD being applied to medical devices.
CLIA Waiver: The Clinical Laboratory Improvement Amendments of 1988 (CLIA) law specified that lab requirements be based on the complexity of the test performed and established provisions for categorizing a test as waived. Tests may be waived from FDA oversight if they meet certain requirements, which define waived tests as any of the following: 1) simple lab examinations and procedures that are cleared by the FDA for home use; 2) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or 3) pose no reasonable risk of harm to the patient if the test is performed incorrectly. Examples of CLIA waived tests include fecal occult blood tests (for colon cancer screening), urine pregnancy tests, blood glucose home monitoring devices, ovulation tests, and other tests that are FDA approved for home use by consumers or healthcare professionals.
- ClinicalTrials.gov (www.ClinicalTrials.gov) is a registry of federally and privately supported clinical trials conducted in the United States and around the world and offers up-to-date information for locating federally and privately supported clinical trials for a wide range of diseases and conditions.
A clinical trial can be summarized as a research study conducted in human subjects in order to answer specific health questions (e.g. does an experimental treatment provide any benefit to patient, what are the side effects associated with a treatment, is one treatment better or safer than another in the treatment of a disease). Clinical trial results may be presented at medical conferences, which is especially common for cancer drugs with multiple conferences held each year for this drug class--including AACR, ASCO, ASH and many others along with medical conferences for other disciplines such as neurology (AAN). Presenting initial clinical trial data at a medical conference often serves as a strong trading catalyst since most results are announced via press release during an estimated time period (e.g. guidance is often to report results during a specific quarter or month of the year so the exact timing of the results usually is not known).
Investigational New Drug (IND) application: a new drug or treatment that is being evaluated in a clinical trial and is not yet approved by the FDA; IND clearance is required from the FDA prior to beginning clinical trials with a 30-day review period after which the sponsor may begin the clinical trial if no objections are raised by FDA.
Investigational Device Exemption (IDE): allows an experimental medical device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification 510(k) submission to FDA to obtain full marketing clearance and begin generating sales. IDE filings are also subject to a 30-day review period after which the sponsor may begin the clinical trial if no objections are raised by FDA.
Phase I Clinical Trial: a small research study that is usually conducted in small number of healthy subjects (i.e. 20-50) to assess the safety of an experimental treatment. This is the first clinical trial conducted in humans after Investigational New Drug (IND) clearance from the FDA that usually includes paid volunteers (with exceptions for HIV/AIDS and cancer drugs that involve patients with the disease) with an average duration of one year. Phase I clinical trials may also assess multiple doses of an experimental drug and combinations with other treatments (i.e. Phase Ib studies).
Phase II Clinical Trial: a small research study (e.g. 50-250 patients) that is conducted with a primary goal of establishing preliminary effectiveness of an experimental treatment in a limited population of patients with a disease or condition, in addition to further assessing the safety profile and side effects. Phase II clinical trials usually take a few years (i.e. 1-3 years) to complete and establish the parameters (e.g. dosing, outcomes, etc.) to be evaluated in a larger Phase III clinical trial to support regulatory approval.
Phase III Clinical Trial: a large research study (e.g. hundreds or thousands of patients) conducted to confirm preliminary effectiveness and safety results obtained in smaller, earlier stage clinical trials that is conducted in a larger population of patients with a disease or condition to provide the basis for regulatory approval. Phase III clinical trials usually compare an experimental treatment with the standard of care (SOC) therapy by randomizing patients to receive an experimental treatment plus SOC vs. placebo plus SOC to evaluate the potential benefit of an experimental intervention.
Phase IV Study: post-marketing clinical trials conducted after regulatory approval to provide additional information on safety and effectiveness for an approved use; this may be required by the FDA as part of a conditional approval for a new treatment
Special Protocol Assessment (SPA): a procedure through which the FDA provides official evaluation and written feedback on the design, clinical endpoints, size, and data analysis of a planned pivotal clinical trial (i.e. one designed to support a NDA or BLA filing for FDA approval) to ensure that the agreed upon study protocol meets FDA expectations to support regulatory approval if statistically significant and consistent data for the primary outcome is obtained along with an acceptable safety profile. The current FDA performance goal is to review and respond to 90% of SPA requests within 45 days of receipt.
- www.StockCharts.com: a good source for charts and basic technical analysis overview & often used in BioRunUp.com articles
- Drugs.com (http://www.drugs.com/rss.html): offers news feeds and email updates for FDA and clinical trial news
- EMA / CHMP European Regulatory news and events (monthly CHMP meetings & agendas--the image below provides an overview of the EU regulatory approval process). The EMA now publishes an agenda around the start of each monthly meeting (Monday or Tuesday) & the meetings conclude on Thursday with an official summary of the outcomes published Friday morning (some decisions are announced before the official meeting summary is published).
- OTC Markets (http://www.otcmarkets.com/home): more specific research for stocks that trade on the OTC Markets
- Google Finance (https://www.google.com/finance): similar to Yahoo Finance with ability track companies, key statistics, charts and news headlines