VivaGel® BV Launch(es), page-21

if you are invested in SPL for short term reasons you are in the wrong stock.
The only thing that matters is getting it right first time in medicine. If you screw it up the reputational damage is terminal.
We can speculate as much as we like as to the reasons for the delay, but I am happy to sit and wait.
It either works or it doesn't. the science says it does. There are no other options for treatment on the horizon so a few months here or there is inconsequential.
At the beginning of the year we had a "guess what the share price will do" thread. So far, it is doing pretty much what I thought.
I would anticipate a further drift down for a month or three (or six) until the next milestone announcement re FDA final submission and approval. These represent buying opportunities. Nothing more.

The only major concern would be scale up manufacturing issues re product quality. If that is the case then we could be in trouble until they are resolved.