Nephros, Inc. (OTC: NEPH)
A reader of StocksHaven Investments by the name of Michael Sklar has contributed the following article regarding Nephros, Inc. The article outlines one of the most undervalued BioPharma companies around, at only $1.08 PPS with three pending FDA decisions. If you are an avid investor of pre-PDUFA companies, StocksHaven Investments highly suggests you conduct some due diligence on this company, as its potential value greatly outweighs the risks involved.
About: Nephros, Inc. (Nephros) is engaged primarily in the development of hemodiafiltration (HDF), products and technologies for treating patients with end stage renal disease (ESRD). The Company has three products in various stages of development in the HDF modality to deliver therapy to ESRD patients: OLpur MDHDF filter series (which it sells in various countries in Europe and consists of its MD190 and MD220 diafilters); for HDF therapy and employing its Mid-Dilution Diafiltration technology; OLpur H2H, the Company’s add-on module designed to allow the most common types of hemodialysis machines to be used for HDF therapy, and OLpur NS2000 system, its stand-alone HDF machine and associated filter technology. Nephros has also developed its OLpur HD 190 high-flux dialyzer cartridge, which incorporates the same materials as its OLpur MD series but does not employ its Mid-Dilution Diafiltration technology.
Nephros, like many other BioPharma companies these days is waiting for an FDA decision, actually they are waiting for three. Currently the FDA has made many investors in this sector ride through bi-polar roller coasters. One of the major reasons is the appointing of a new FDA director. This is understandable because anytime a new director comes on board there is a transition stage. Day traders might be raking in the money because of all the nervous investors out there who might not be as patient as others, however, people investing with long positions are investing because they truly believe in the company.
Nephros is waiting on decisions on the following 3 Class 2 510(k) applications:
The Nephros hemodiafiltration (HDF) system is designed to improve the quality of life for End-Stage Renal Disease (ESRD) patients while addressing the critical financial and clinical needs of the care provider. The HDF system removes a range of harmful substances more effectively, and with greater capacity, than existing ESRD treatment methods, according to the Company. On 11/14/08, Nephros submitted a 510(k) application to the FDA for approval of its HDF products for ESRD in the U.S. market. Following its review of the application, the FDA has requested additional information. Nephros replied to the FDA inquiries on 3/13/09. Per FDA guidelines, the FDA has 90 days to review the additional information provided by the Company for an estimated PDUFA of Friday 6/12/09 or Monday 6/15/09.
On 10/7/08, Nephros filed a 510(k) application for approval to market its Dual Stage Ultra-filter (DSU filters) to dialysis clinics for in-line purification of dialysate water. Following its review of the application, the FDA requested additional information, and Nephros provided a formal response to the agency on 2/24/09. Per FDA guidelines, the FDA has 90 days to review the additional information provided (5/26/09), but a response from the agency is still pending.
The FDA’s authority over devices dates only to 1976, when they decided to make 3 classes. One way of prioritizing was to assign categories of risk associated with the devices. Rubber gloves seemed less risky than cardiac pacemakers, for example. So the agency assigned devices to 1 of 3 levels of scrutiny. Class I devices have low risk; oversight, performed mainly by industry itself, is to maintain high manufacturing quality standards, assure proper labeling, and prevent adulteration. Latex gloves are an example.
