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Biotech / Medical : Breakthrough Company????? Endovasc ENDV -- Ignore unavailable to you. Want to Upgrade?

To: Dr David Summers who wrote (57)	5/3/1999 12:34:00 PM
From: Dr David Summers	Respond to of 94

Thanks NY_Know I don't think any of our so-called DD seekers (bhsl, especially) are interested in the financial aspects or the potential return on investment. It looks to me that they are only looking to nit-pick at the perceived flaws in the tapestry. The Navajos always leave a tiny flaw in their weaving, so they cannot proclaim perfection. It's called "letting the devil out." So here we go one more time. 1. Orphan Drugs: HP Type is partially correct. The other part is that it cannot be classified "Orphan" if there are more than ca 150,000 patients in the class. We are not seeking government financial help, only that the 100,000 or so amputations from critical limb ischemia (CLI) (because there is no effective medical treatment) be put into this class so we can test the therapeutic effects of PGE-1 on reperfusion and limb salvage. Most of these folks are diabetics or heavy smokers. He's right; FDA may not consider them as a special class. 2. Compassionate Need: Partially right again, but misses the point. We are not looking for government funding to defray costs. Compassionate need is also considered when a new medical therapy may eliminate or reduce certain inevitable outcomes, e.g., surgical amputation of a limb. Currently (unless HP knows something that I don't), CLI is always a life-threatening disease without revascularization (which is usually surgical) or amputation. In conclusion, we do not expect to open Ft. Knox with our first indication. What we expect to do is to demonstrate the therapeutic benefits of Liprostin (TM) in this undertreated group of patients. With the data gain in this approval, we will then be able to go to the holy grail; the vast market for elimination or reduction of vascular restenosis. David P. Summers, FACA