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Biotech / Medical : ACMI - Accumed Inc. -- Ignore unavailable to you. Want to Upgrade?

To: Frank Buck who wrote (960)	1/6/1998 2:09:00 PM
From: XaviarCane	Read Replies (1) \| Respond to of 1894

Wow, up 1/4. I hope it can hold on. -Xaviar

To: Frank Buck who wrote (960)	1/6/1998 8:31:00 PM
From: Sigmund	Read Replies (1) \| Respond to of 1894

Of course I wasn't there but according to my broker, NeoPath was told that the FDA wanted their product approved. And based on this they went before the advisory board thinking that what they had was good enough. They were wrong, surprised and set back. My understanding is that now they have followed a protocol which was recommended to them by those who should know what is required. From what I hear they have good results. We will see. Being a good research person does not make one a good regulatory approval person. NeoPath management may not have taken the steps necessary to fully understand the FDA process i.e. retain a competent consultant. We have an environment now where individual companies are attempting to get the FDA to rule negatively on the products of their competitors. This can not be a one way street. If this type of "competition" wins out it is reasonable to conclude that the FDA will find it best to be hard on all of the competitors. This point is so obvious to me that I don't understand why it seems strange to you. Take a look at the telecom environment. All of the companies find it difficult to get anything approved because every move is challenged by competitors and the FCC must be careful to be seen as evenhanded. It doesn't make for rapid progress. It wouldn't help ACMI if some of the competitors complained about the use of the 510(k) process. Clearly the ACMI product is different from the products previously approved or there would be no benefit to the product and no reason to approve it. If the NeoPath AutoPap is rejected and NeoPath objects to the use of the less rigerous 510(k) process with respect to a product that in some way is similar i.e. it is automation, this might carry some weight. Perhaps ACMI has competitors that can file an even more compelling complaint. Thus I conclude that a nervous FDA is not in the best interests of any of the companies in this sector. I think the decline in the prices of the stocks in this sector is partially a result of the negative competitive environment in the sector. The NSIX/CYTC/NeoPath situation in particular has I believe soured many investors in the entire sector. It only creates risk for investors and investors don't much like risk. I think the comments by the ACMI IR person on this thread re the Pathfinder product were unfortunate. Salespeople need to compare their products to the competition in order to make sales. IR people should adopt a more positive approach and not encourage the sniping which is endemic within this sector. The enemy is disease not the competition.