To: The Dodgy Ticker who wrote (1 ) 1/26/2004 6:58:59 PM From: Area51 Read Replies (1) | Respond to Hi Bob, sec.gov To obtain regulatory approvals, we must, among other requirements, complete carefully controlled and well-designed clinical trials demonstrating that a particular product candidate is safe and effective for the applicable disease. Several biotechnology companies have failed to obtain regulatory approvals because regulatory agencies were not satisfied with the structure or conduct of clinical trials or the ability to interpret the data from the trials; similar problems could delay or prevent us from obtaining approvals. Furthermore, we initiated our Phase III Oncophage clinical trials in renal cell carcinoma and melanoma before the FDA’s Special Protocol Assessment program was available, and we, therefore, do not have a determination by the FDA that these trials are pivotal and can form the primary basis of an efficacy claim in a BLA. We plan to initiate two additional confirmatory Phase III trials for Oncophage during 2004 — one in renal cell carcinoma and one in melanoma. We intend to use these additional Phase III trials to support potential accelerated approval filings from our current Phase III trials in renal cell carcinoma and melanoma. We have not had detailed discussions with the FDA regarding our product approval strategy for Oncophage, however, and the FDA has not yet reviewed the protocols for the new planned Phase III Oncophage trials. The FDA may not consider these trials to be confirmatory trials in our current Phase III development program and may disagree with our overall strategy to seek accelerated approval. In this event, the potential commercial launch of Oncophage could be significantly delayed, which would likely have a materially negative impact on our ability to generate revenue and our need for additional funding. smartmoney.com
