Replies to post #13191 on Seelos Therapeutics Inc (SEEL)

[Dimitrios George]

Okay, this is not rocket science.

Think of cold chain Vitaros as a two component (alprostadil and DDIAP) epoxy that has been mixed but won't set up if refrigerated. At room temperature the epoxy sets up. In the case of Vitaros, at room temperatur the alprostadil starts degrading when mixed with the other chemicals.

In room temperature Vitaros, the two components (alprostadil and DDAIP) are kept in separate sealed containers in a dispenser...just like the epoxy you buy at a hardware store that comes in a dispenser. When you press the plunger, the two components mix. What comes out of the nozzle is the same as cold chain Vitaros. Simple.

But as a medical device you have to prove that it works as designed. If you want to claim that the device will work for two years at room temp, you have to fill a number of dispensers, set them aside for two years, then test what comes out of the nozzle. It takes time. Again, not rocket science. There is not a science issue.