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Biotech / Medical : dsco Discovery Laboratories

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To: Arthur Radley who wrote (136)	10/7/2007 4:04:40 PM
From: detlef gerlach	Read Replies (1) of 318

Feuerstein's comments are not based on any special insight. He is basically trashing the company and does not appear to have anything constructive to add. There is no doubt that investing in Discovery has been a roller coaster experience filled with frustrations and dissappointments. The management and the previous folks running the manufacturing screwed up big time. The previous VP of manufacturing has left(with millions of our dollars) and Charles Katzer from Medimmune has taken over as senior VP of manufacturing. At Medimmune he was instrumental in manufacturing and distributing vaccines which requires attention to details that we need in the manufacturing of Surfaxin. I hope he comes through at Discovery Labs. Don't forget that Surfaxin has been manufactured in large enough quantities in the past with a shelf life adequate to carry out all of the clinical trials, WHICH WILL NOT HAVE TO BE REAPEATED. Whatever happened in the past to result in only an Approvable Letter from the FDA primarily focused on the CMC section of the Surfaxin NDA and was most likely caused by lack of attention to detail during and after the acquisition of the manufacturing facility. Hopefully they now have a better understanding of the problems that the FDA pointed out to them. The FDA requires a shelf life stability of 6 months, which they SEEMED to have achieved in all of their 2007 validation test batches, but they would obviously like at least 12 month stability. When the FDA accepts their new data for review I will feel a little better, but until Surfaxin is approved there are no guarantees. I hope and expect that the management understands that one more Approvable Letter and the company might as well pack it's bags. I have been invested in this company for many years and hope they will do it this time. Unfortunately the potential return in investment today is not as great as it was when I originally bought stock in the company. This stock has gone up and then back down again after every positive announcement-a reflection of the lack of confidence in the management. I do not worry about these ups and downs but try to focus on the fundamentals. This is Discovery Lab's last chance and the possibility of another screw is certainly there. Buyer beware, this is a risky investment.

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