Biosante Pharmaceuticals Inc. (NASDAQGM: BPAX ) BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism. BioSante’s lead products include LibiGel® (transdermal testosterone gel) in Phase III clinical development by BioSante under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction (FSD), and Elestrin™ (estradiol gel) developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, currently marketed in the U.S. by Azur Pharmaceuticals. Also in development are Bio-T-Gel™, a testosterone gel for male hypogonadism, and an oral contraceptive in Phase II/III clinical development using BioSante patented technology. The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion and for oral contraceptives approximately $3 billion. The company also is developing its calcium phosphate technology (CaP) for novel vaccines, drug delivery and aesthetic medicine (BioLook™).

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        In October 2016, the Company’s stockholders approved the 2016 Employee Stock Purchase Plan (the "2016 ESPP"), which gives eligible employees the right to purchase shares of common stock at the lower of 85% of the fair market value on the first or last day of an offering period. There were 175,000 shares of common stock initially reserved for issuance pursuant to the 2016 ESPP. The number of shares of common stock that may be issued under the 2016 ESPP will automatically increase on each January 1 equal to the lesser of: (i) 300,000, (ii) 1% of the Company’s shares of common stock outstanding on the immediately preceding December 31 or (iii) an amount determined by the administrator of the 2016 ESPP appointed by the Company’s board of directors. During the years ended December 31, 2018 and 2017, the Company issued 6,326 and zero shares of common stock under the 2016 ESPP, respectively. As of December 31, 2018, there were 620,401 shares available for future grant under the 2016 ESPP and on January 1, 2019, this number increased by 300,000 shares.

Oops, my comment that Josh is one of our scientific advisors seems to have been posted outside of this thread. Please see below.

5.        The Company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Company’s auditors and the audit committee of the Company’s board of directors (or persons performing the equivalent function):

Biovest International Inc. (OTCPK: BVTI ) Biovest International, Inc.is a pioneer in the development of advanced individualized immunotherapies for life-threatening cancers of the blood system. Biovest is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCPK:ABPIQ ) with its remaining shares publicly traded. Biovest has a foundation in the manufacture of biologics for research and clinical trials. In addition, Biovest develops, manufactures and markets patented cell culture systems, including the innovative AutovaxID™, which is being marketed as an automated vaccine manufacturing instrument and for production of cell-based materials and therapeutics. Biovest recently completed a pivotal Phase 3 clinical trial for BiovaxID®, which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin’s lymphoma. BiovaxID has been granted Fast Track status by the FDA and Orphan Drug status by the EMEA.

Drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and some state agencies for compliance with cGMP and other laws.

Pursuant to the terms of the Samil Agreement, following the first achievement of US$25 million of net sales in any calendar year following the first commercial sale of the Product in the Territory, Samil shall have the option to request that the Licensed Information include methods for the formulation of Aramchol from its API, to allow for the manufacture of Aramchol by Samil; provided, however, that we shall have the option, to widen the definition of the Licensed Information as aforesaid at any time.

The results from echocardiography were confirmed by heart macro morphology and biochemistry studies. CH occurred obviously in AAS1M rats, and further exaggerated in AAS2M, as indicated by the increase in whole-heart cross section area and cardiomyocyte size (Fig. 2a,c), as well as in the ratio of heart weight (HW) to body weight (BW) (Fig. 2b). All drug treatments but DO significantly protected against these alterations compared to AAS2M, with QSYQ being the most effective one. Of interest, ASIV+DLA+R1 showed an effect comparable to QSYQ (Fig. 2a–c).

Additional time may be required to obtain regulatory approval for our product candidates because they are combination products.

        The Company is not a party to any known litigation and does not have contingency reserves established for any litigation liabilities.

        Our common stock has been trading on The Nasdaq Global Market under the symbol "RARX" since it began trading on October 26, 2016. Prior to this date, there was no public market for our common stock.