FDA’s Record Approvals Bode Well for PharmaCyte’s Cancer Treatments

Biotech stocks have been on fire since the start of 2015 and there is no sign of the money flows abating anytime soon. For the first quarter of 2015, biotech ETF bellwether iShares NASDAQ Biotechnology (NASDAQ – IBB) was up 13% while the SPDR S&P Biotech ETF (NYSE – XBI) rose around 20%. It should be noted that the SPDR ETF is comprised of small to midsized biotech stocks. Since we are in the midst of a biotech acquisition and investment boom that seems to occur on an almost daily basis, it is no surprise that the performance of the smaller biotech stocks is greater than their larger, acquisitive brethren. Still, biotechs are not under such broad accumulation due to M&A alone. In fact the real driver should result in a rising tide lifting all biotech boats, including shares of biotech pioneer PharmaCyte Biotech (OTCQB – PMCB - $0.1375 – Spec Buy).

The primary driver behind the rise in biotechs may be the Federal Drug Administration (FDA) itself. Last year, it approved 41 new drugs which, according to the organization’s website, were the most in nearly 20 years. That figure is up from 27 in 2013---a 51% increase year-over-year. Could it be that the FDA has become more accommodating in its goal of more swiftly approving drugs for treatment of diseases, especially those that are rare and serious diseases? It certainly seems that quality of life, especially in the treatment of life-threatening diseases has emerged as a key determining factor, which sets up very nicely for PharmaCyte Biotech.

Of the 41 approved drugs, eight were to treat cancer and four to treat type-2 diabetes. However, 17 (41%) of the drugs were approved to treat rare diseases that affect 200,000 or fewer Americans. In fact, that figure is the highest yearly total of such drugs ever — even surpassing the previous high of 13 from 2012. That is a great sign for companies such as PharmaCyte Biotech which is right in this sweet spot. The Company’s flagship technology, Cell-in-a-Box®, has recently been granted this Orphan Drug Status by the FDA for the treatment of advanced, inoperable pancreatic cancer when used in combination with the chemotherapy drug ifosfamide at one-third the dose normally given.

Moreover, to expedite the development and review of these drugs the FDA used a number of regulatory programs, including Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval. Half of the approved drugs were fast track or breakthrough and nearly two-thirds were designated for Priority Review, meaning that the FDA saw potential for providing a significant advance in medical care, and set their review target to within six instead of the standard 10 months.

Clearly this enhanced approach by the FDA has had a great impact on biotech stocks and bodes well for companies like PharmaCyte Biotech, should they be entered into any of the accelerated review tracks above. In any event, the FDA’s current accommodative stance should continue to serve as a biotech stock driver going forward.

For more information, refer to our previous sponsored PMCB Reports, Updates and Hot Topic Articles by visiting http://www.GoldmanResearch.com/

Senior Analyst: Robert Goldman

Rob Goldman founded Goldman Small Cap Research in 2009 and has over 20 years of investment and company research experience as a senior research analyst and as a portfolio and mutual fund manager. During his tenure as a sell side analyst, Rob was a senior member of Piper Jaffray's Technology and Communications teams. Prior to joining Piper, Rob led Josephthal & Co.'s Washington-based Emerging Growth Research Group. In addition to his sell-side experience Rob served as Chief Investment Officer of a boutique investment management firm and Blue and White Investment Management, where he managed Small Cap Growth portfolios and The Blue and White Fund.

Analyst Certification

I, Robert Goldman, hereby certify that the view expressed in this research report accurately reflect my personal views about the subject securities and issuers. I also certify that no part of my compensation was, is, or will be, directly or indirectly, related to the recommendations or views expressed in this research report.

Disclaimer

This Microcap Hot Topics Article was prepared for informational purposes only.

Goldman Small Cap Research, (a division of Two Triangle Consulting Group, LLC) produces research via two formats: Goldman Select Research and Goldman Opportunity Research. The Select format reflects the Firm’s internally generated stock ideas along with economic and stock market outlooks. Opportunity Research reports, updates and Microcap Hot Topics articles reflect sponsored (paid) research but can also include non-sponsored microcap research ideas that typically carry greater risks than those stocks covered in the Select Research category. It is important to note that while we may track performance separately, we utilize many of the same coverage criteria in determining coverage of all stocks in both research formats. Research reports on profiled stocks in the Opportunity Research format typically have a higher risk profile, and may offer greater upside. In 2015, Goldman Small Cap Research has been compensated by a third party in the amount of $6500 for a research subscription service and a series of articles. Our analysts are responsible only to the public, and are paid in advance to eliminate pecuniary interests, retain editorial control, and ensure independence. Analysts are compensated on a per report basis and not on the basis of his/her recommendations.

Goldman Small Cap Research is not affiliated in any way with Goldman Sachs & Co.

The information used and statements of fact made have been obtained from sources considered reliable but we neither guarantee nor represent the completeness or accuracy. Goldman Small Cap Research did not make an independent investigation or inquiry as to the accuracy of any information published by the Company, or other firms. Goldman Small Cap Research relied solely upon information published by the Company through its filings, press releases, presentations, and through its own internal due diligence for accuracy and completeness. Statements herein may contain forward-looking statements and are subject to significant risks and uncertainties affecting results.

Separate from the factual content of our articles about the Company, we may from time to time include our own opinions about the Company, its business, markets and opportunities. Any opinions we may offer about the Company are solely our own, and are made in reliance upon our rights under the First Amendment to the U.S. Constitution, and are provided solely for the general opinionated discussion of our readers. Our opinions should not be considered to be complete, precise, accurate, or current investment advice. Such information and the opinions expressed are subject to change without notice.

A Goldman Small Cap Research report or article is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed. This publication does not take into account the investment objectives, financial situation, or particular needs of any particular person. This publication does not provide all information material to an investor’s decision about whether or not to make any investment. Any discussion of risks in this presentation is not a disclosure of all risks or a complete discussion of the risks mentioned. Neither Goldman Small Cap Research, nor its parent, is registered as a securities broker-dealer or an investment adviser with FINRA, the U.S. Securities and Exchange Commission or with any state securities regulatory authority.

ALL INFORMATION IN THIS REPORT IS PROVIDED “AS IS” WITHOUT WARRANTIES, EXPRESSED OR IMPLIED, OR REPRESENTATIONS OF ANY KIND. TO THE FULLEST EXTENT PERMISSIBLE UNDER APPLICABLE LAW, TWO TRIANGLE CONSULTING GROUP, LLC WILL NOT BE LIABLE FOR THE QUALITY, ACCURACY, COMPLETENESS, RELIABILITY OR TIMELINESS OF THIS INFORMATION, OR FOR ANY DIRECT, INDIRECT, CONSEQUENTIAL, INCIDENTAL, SPECIAL OR PUNITIVE DAMAGES THAT MAY ARISE OUT OF THE USE OF THIS INFORMATION BY YOU OR ANYONE ELSE (INCLUDING, BUT NOT LIMITED TO, LOST PROFITS, LOSS OF OPPORTUNITIES, TRADING LOSSES, AND DAMAGES THAT MAY RESULT FROM ANY INACCURACY OR INCOMPLETENESS OF THIS INFORMATION). TO THE FULLEST EXTENT PERMITTED BY LAW, TWO TRIANGLE CONSULTING GROUP, LLC WILL NOT BE LIABLE TO YOU OR ANYONE ELSE UNDER ANY TORT, CONTRACT, NEGLIGENCE, STRICT LIABILITY, PRODUCTS LIABILITY, OR OTHER THEORY WITH RESPECT TO THIS PRESENTATION OF INFORMATION.

For more information, visit our Disclaimer: www.goldmanresearch.com