Finally proof I can get my arms around on why 510k is delayed. This ought to bolster PPS taking the "blame for delay" out of NEPH's hands and placing it squarely in the FDA's shoulders.
And from the article:
"In a letter to Shuren last week, members of the Massachusetts congressional delegation urged the agency “to avoid unnecessary regulatory barriers that will needlessly lengthen the review and approval process,’’ especially for small companies trying to bring new technologies to market."
Let's hope the letter wakes someone from the FDA up...
also...long story short the 510k timeline, at this point, is 100% normal. There is no negative reason for the pending status length other than the FDA is very slow in processing 510k medical device applications for EVERYONE....
And current PPS is based on investor fear that the present timeline equates to a greater likelihood for denial which it does not.
With current devices on the market, improved sales quarter over quarter, low float-NEPH, IMO is grossly oversold..
Wow. VERY interesting article. It pretty much sums up everything we all have thought up to now. The FDA is ridiculously slow, inconsistent, inefficient and is paralyzing startup biotechs with their rule changes mid-way through the entire process. I personally think device companies with pending 510k's should be grandfathered in under the previous FDA rules, because it really is unfair to change the rules midway and expect a biotech company to proceed in a new direction, especially when the previous FDA assisted with such applications. It is just absurd that the FDA can so blatantly mismanage a device approval process without any recourse given to investors. It is just an example of how damaging big goverment can be to its own citizens, when it can do whatever it wants without any fear of punishment, no matter how stupid, unfair or inefficient they are.