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Biotech / Medical : Biotime-Nasdaq's best kept secret? -- Ignore unavailable to you. Want to Upgrade?

To: Jim Roof who wrote (999)	6/9/1998 10:30:00 AM
From: mesaone	Respond to of 1432

this is pennsylvania merchant groups buy recommendation dated june 3rd. analayst is michael martorelli. we continue to recommend btim as an attractive speculation, but only for investors with a strong tolerance for mischief and uncertainity. at the end of the day, it will be the FDA (not individual physicians or investors writing threads on intenet chat roms) that will decide 1. whether to accept btim's new drug application for its lead product hextend, and 2. whether the product is safe and effective enough to be approved. further, itw ill be the hospital and anesthesoiologist customer base of abbott las (not individual physicians contacted by reporters or analysts) that will decide how successful the product will be on the marketplace. in the absence of any hard data on any of those three important issues, we believe the stock will continue to a volatile playtoy of both the longs andthe shorts. Indeed facts will determine the outcome of the BTIM investment story. we remain confident in the company's management, its business plan, and in the relative attractiveness of it's stock. BTIM's management and its regulatory consultant communicated with fda personnel and recieved their permission to forgo phase 1 and II trials of hextend. permission to proceed with the 117 patient phase III trials was based on the per-existing knowledge of Hexten's components and widespread clinical use of the drug substance hetrastarch. It would be naive to assume that any particular company could never misinterpret the fds's comments regarding a clinical trial program, or that every company that completed a phase III trial completed it correctly. On its face, however, the phase III trial that is the basis of the hextend NDA does seem to have been completed satisfactorily, i.e. no inordinate number of patient dropouts and no large gaps in the data collected.

To: Jim Roof who wrote (999)	6/9/1998 10:32:00 AM
From: mesaone	Read Replies (1) \| Respond to of 1432

rec. part 2. <- Previous Next -> Message 1896 of 1901 Reply more of the recommendation mesaone Jun 9 1998 9:11AM EDT further, while we have not seen the rest of the nda, we are confident that it includes all reelvant chemitry data about the well known ingredients of hextedn, and the manufacturing data as supplied by the company's manufacturing and marketing partner abbott labs. we are hopeful that teh fda will announce its acceptance of hextend nda during the next week or two, and continue to expect an approval in about 12 months. predicting the fda's action an any nda is highly speculative. the pivotal phase III trial appeared to demonstrate the equivalence of hextend to hespan, based on the primary endpoints of urine output, heartrate, and blood pressure. further, hextend patients who required an interoperative transfusion experienced one liter less blood loss than the transfused hespan patients. the trial also appeared to demonstrate the products safety, in that it was given in volumes up to 5 liters and in volumes in excess of 1.5 liters to 42% of the 59 patients who received hextend in the trials. based on the clinical effectiveness, we see no reason why hextend should not be approved. and based on the dosages used, we see no reason for the products label to carry any artificially low dosage limitations. during the next several weeks, physicians at middlesex hospital in london are scheduled to begin another hextend trial. the protocole for this study is not yet finalized, but it will probably involve 40-70 patients. investigators will be using ether hextend or hespan as a plasma volume expander in similar groups of patients over 65 years old undergoing high blood loss surgeries. management has long believed hextend's proprietary mixture of hetastarch plus electrolytes and buffers will allow it to replace hespan and other volume expanders such as colloids, crystalloids, and albumin. while the first trial was designed to show only that hextend could be used safely and effectively in large volumes, this one should illustrate its superiority over other products when used in a typical clinical setting. it should be completed early next year. recently, abbott labs has begun publicly discussing its interest in hextend. we understand that the company to have estimated the present US market for all plasma volume expanders at $400-$500 million, not just the limtied $30 million existing hespan market. we continue to believe in the ability of abbotts sales organization to take the hextend message to the wdest possible audience, and to help the product achieve anualized sales in te neighborhood of $200 million within two years of the products introduction. based on teh ABT/BTIM marketing agreement, that level of annual sales would generate revenues of approximately $92 million to BTIM . as noted in the first paragraph of this research brief, we continue to believe in the prospects for both btim and its lead product. the company should be starting toxicology and pharmacology studies on its follow up product, pentalyte later this year, but we'll save further commentary on that productfor another time. we are more frustrated by the performance of this stock than of that of any other equity in our coverage universe, especially since its downward trend of the past 6 months has not been related to any tangible, fundamental changes in the company's propspects. management of btim has been as forthcoming with information and as accurate in their predictions about near term events as any managment team we have ever met. we continue to reccomend purchase of this stock.