Dave, I think you are getting your studies conf
Post# of 30028
Posted On: 09/02/2014 1:44:26 PM
Re: Daveludlow #5257
Dave,
I think you are getting your studies confused again. The 160-subject validation study is done. It was presented in Copenhagen and done analytically by BD using past data from version 1. Basically, they were confirming the original version 1 data from Provista, which was a very important step in the "history" of Lympro data.
The Bridge Study is currently ongoing and will measure version two vs. version 1. Supposedly, the early returns were quite positive.
The most important data (other than the Bridge Study) will now come from the CLIA process. The data obtained from this will be the basis for the FDA process of approval. The test will be used in real studies and provide real data over a large sample size.
Others -- please correct me if I am incorrect with this interpretation.
I think you are getting your studies confused again. The 160-subject validation study is done. It was presented in Copenhagen and done analytically by BD using past data from version 1. Basically, they were confirming the original version 1 data from Provista, which was a very important step in the "history" of Lympro data.
The Bridge Study is currently ongoing and will measure version two vs. version 1. Supposedly, the early returns were quite positive.
The most important data (other than the Bridge Study) will now come from the CLIA process. The data obtained from this will be the basis for the FDA process of approval. The test will be used in real studies and provide real data over a large sample size.
Others -- please correct me if I am incorrect with this interpretation.
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