They need new data, and that data has to show something different than the existing data. Gathering data requires money, and money, they don't have.
They've known they need new data since before 2012, and they keep trying to stuff the square peg into the round hole. This is the third "not approvable" letter, and I remember the first one, which said "we don't like the data".
They were going to raise money at $.50 if FDA approval came through; now they're going to raise money at $.05.
The story is not over, but it's potential ending is much less grand. So either sell and move on, or increase your ownership to reflect significant dilution.
It's going to be at the same market cap in 10 years, just a lot more shares outstanding than we all had hoped.
Once FDA approves, we'll most likely get a formal partnership with someone for U.S. distribution. The pockets will get deeper and the risk of financial ruin will become minimal. That is the reason FDA is so important.
Gene said on the call that in Indonesia the screening rate is 1-2% of the population. We're trying to not only sell our product, but sell screening in general. The process of creating change and cutting through government red tape is not going to be completed quickly. But traction is gaining.
Complacency is a positive here. Three months ago bankruptcy appeared to be a virtual certainty; it is now just a likely possibility, but so is success.
As far as I know there is no question about safety; both the company and FDA agree the product is safe.
The problem is in the study they have been trying to use for approval. Standard of care changed after the study, the product was modified, and the study did not meet its endpoint of 99% specificity- it was 98%... That is depending on how you calculate results.
They don't want to convene a panel since that counts against their internal measurements due to the high cost.
The odds of "conditional approval pending a flow-up study" are much higher than most people think, IMO.