Isotechnika Pharma Inc IPHAF

RE: " stability testing " ?

[snrkid]

labumba, 

I value your opinions but are you sure this could have been done "years ago"? 

The drug that is being applied for NDA approval must be specific strength, specific formulation, capsulation etc.  This testing will not be a long term process and it must be likely done by an  independant facility to determine shelf life of product, storage conditions  etc.  Prior to determining the applied formula strength I find it hard to do testing.

When management is talking about this type of stability determination I find it very encouraging and see the light on the end. 

My understanding is that Voclosporine used for uventis may have different requirement than Voclosporine used for Psoriasis for example.  This is the same drug but requirements may differ as you can find when simply looking for information at public domain.  I personally don't see this as oversite just part of process.

happy trading....
snrkid.