Dave, this is what I think about Lympro. GC never gave any real dollar figures on it that was tied to a fixed date. He did say that it was an IUO test and that with the start of sales it would generate revenue. As an IOU it can only be used in the lab that it received its approval in.
The next step is to get it CLIA approved so that it could be used in other CLIA labs and could perhaps have more use to customers (BP). AMBS now has a person other than GC to go out and sell it.
Then FDA approval so it can be used by doctors.
Now all the studies that are currently undergoing are not going to stop in the middle and start using a new test. Lympro is going to have to be sold to companies that are starting new test. I believe that means a test that hasn’t received its IND yet. That is because the FDA has to approve the testing criteria before it issues the IND. So that means any new customers are those just now putting in their IND for a study and I am sure that takes some time. So for me, I think 4th quarter would be the earliest that AMBS would see any significant revenue or customer.
From all the scientific evidence, it is a good test, so I will go with that.
The next step is to get it CLIA approved so that it could be used in other CLIA labs and could perhaps have more use to customers (BP). AMBS now has a person other than GC to go out and sell it.
Then FDA approval so it can be used by doctors.
Now all the studies that are currently undergoing are not going to stop in the middle and start using a new test. Lympro is going to have to be sold to companies that are starting new test. I believe that means a test that hasn’t received its IND yet. That is because the FDA has to approve the testing criteria before it issues the IND. So that means any new customers are those just now putting in their IND for a study and I am sure that takes some time. So for me, I think 4th quarter would be the earliest that AMBS would see any significant revenue or customer.
From all the scientific evidence, it is a good test, so I will go with that.
