shekels, that is a good question. It is not really known at this time based on the news. I anticipate a conference call to enlighten shareholders by ADMD. At that time they will likely disclose their strategy. I know some may think they know but they do not. It was kinda like the same folks saying that the FDA would approve without any further studies requested by the FDA as I suspected would happen. No one really knows, all you can do is play probablilities right now based on previous similar situations for other companies.
Actually spoke with an ADMD insider, the News coming out is that the meeting with the FDA went well. The reclassification will be coming and the FDA wants this APPROVED QUICKLY, they are only concerned with excretion, which data has been given from a similar product. This should be APPROVED soon (mid 2014)
With a re-filing though, I would assume that most of the information filed on the original application from last November would carry over? Isn't it just a pile of paperwork? 1 year for a re-filing is quite lengthy. Is there more tests/proof of concept they have to do for a reclassification?