I think we can all guess right now that a large scale study is going to be required...meanwhile DVAX is diluting the PPS with its offering announced last month to raise funds to finance that trial which I think will take 6 months to complete and then another 6 months to get before VRBPAC again.....and yes I do think DVAX files in June for CKD use and gets partial approval before yearend.......finally EU likely does not approve at this time either.............what does the new larger trial do to the PPS since it has not been formally announced even though it is widely expected? My view is that the stock drops to $1.80 again for a couple of weeks and then works its way back to $5 by the Spring of 2014.....am I too negative or optomistic here?
I don't think another trial is a given at this point. If some sort of limited approval is provided by the FDA then it is reasonable to assume that it will function to seve as an expanded trial. As with most new drugs, the FDA is going to want to see safety measures and protocols followed until a large enough population as been exposed and it is proven safe for the masses. The bigger problem is the cost of building a sales and manufacturing force should they go it alone. Supposedly this is what the funds raised at the last dilution were to be used for, but I have doubts that this was the case and fully expect to see more more money raised regardless if they receive limited FDA approval or not. Even if they had recieved full approval, it seemed pretty apparent that they would need to raise funds since an EU partnership never developed. Share price will be effected either way, but the true driver of the share price will be sales. there are plenty of companies out there with approved products but no sales (DSCO) - expect pps pressure until that happens.