For the newbies- Here is what is going on with CLXN:
1. An LOI for a FDA approved CLIA waived Rapid test kit is expected anytime. CLIA waived means it can be done in a Doctor's office and does not have to be sent to a lab. They will have a product that can produce alot of revenues immediately.
2. Validation Studies are underway. Basically, a culture of Clamidia is grown in the lab. They then test to see if the chemical agent of the test kit reacts to the culture. Proof the science works. This is more a formality as the test works. Once this is done the product can be sold in Europe, S. America and most of Asia as they do not require FDA approval. Once the culture is grown, the testing takes 2-3 days. The validation studies are used to train the lab people on the protocols that will be used in the clinical trials. This will be completed by the end of May.
3. Announcement of the European Distributor- I believe this company will handle the rest of the world also.
4. Once Validation studies are done, they will move on to the clinicals. This is a test kit so the clinicals are very simplistic. They need to test a certain number of patients to see if it works 400-600. The clinicals will take less than 2 weeks. I am looking for FDA approval by end of Summer to early fall. Then they will have the product China FDA approved.
5. Once the Clamidia test kit has FDA approval, they will move on to Gonorrhea. This test kit will be bigger than the Clamidia test kit.
