Expert Financial Analysis and Reporting

Investment Overview pSivida holds a unique, leading position in developing inserts that provide long acting delivery of drugs to the retina in the back of the eye. Eye drops cannot deliver drugs effectively to the retina and systemic therapy requires large doses of drug to be delivered in order to allow some small part of […]

SmithOnStocks Mailbox About the Mailbox: My mailbox comments are brief articles on stocks in which I am involved. These can come from recent events or from subscribers’ questions. They are meant to address specific issues about these stocks and are not full and balanced reports. Please refer to the Reports section of my website for […]

This Has Been a Tough Correction The recent sharp market correction and rotation out of growth stocks like biotechnology and technology has had a major impact on the small biotechnology names that I specialize in. The correction has been stomach churning for me even though I have been through this many times before. I am […]

Back From BIO CEO Conference I have returned from spending two days at the BIO CEO conference at the Waldorf Astoria in New York City. Through attending presentations or one on one meetings,  I heard presentations from Advanced Cell Technology ACTC), Advaxis (ADXS), Agenus (AGEN), Alexion (ALXN) , Alkermes (ALKM), Aradigm (ARDM), Athersys (ATHX), Celator […]

Highlights of Dinner Last night, January 9, pSivida held a dinner for analysts and investors in New York. The audience had a large number of retail investors and Dr. Paul Ashton; the CEO gave a general, introductory overview of the Company. However, Dr. Ashton did provide some useful information in regard to three potential catalysts […]

Alimera (ALIM) and pSivida (PSDV) released some extremely encouraging news on Iluvien. They said that Alimera had entered into labeling discussions with the FDA and as a result, both parties have agreed that there is no need for the previously scheduled January 2014, Dermatologic and Ophthalmic Advisory Committee meeting. A reasonable assumption is that the […]

Background on the Complete Response Letter This note focuses on the implications of the complete response letter (CRL) received by Alimera (ALIM) for Iluvien. This product was developed by pSivida (PSDV) but was partnered with Alimera. This report deals only with the investment significance for pSivida. Alimera announced that it had received another CRL from […]

Investment Scenarios: The Positive and Negative Case pSivida (PSDV) has a very important binary event upcoming on October 17, 2013; this is the PDUFA date for Iluvien, an ocular implant for diabetic macular edema that was licensed to Alimera (ALIM). I cannot answer the question of whether the government shutdown might delay the PDUFA date […]

Overview of This Week’s Report This week I published a major report on Alimera Sciences and pSivida which led to my recommendation of pSivida. I also comment on Neuralstem’s press release on a rat study modeling the use of NSI-566 neural stem cells in an acute spinal cord injury which showed some encouraging data. The […]