There’s a lot of excitement recently regarding Aderans starting phase II, but I remember back in 2003 when Dr. Washenik spoke about a 5 year timeline from that date until release of a product.
A biotech company will surely meet with roadbumps when testing a product, but I would not be surprised one bit if Aderans’ (and ICX’s) delays were caused by factors other than the sceince behind their technologies. Every new product that seeks FDA approval meets with resistance from interest groups that will be harmed by that new product’s release. Those interest groups can (and do) contact the FDA, and raise any and every objection (whether logical or not) regarding that new product. These objections can certainly affect the FDA’s mindset, and when the interest group that is contacting the FDA is a group of doctors (in our case, HT doc’s that know they will be harmed by the emergence of Aderans and ICX) the FDA will definitely listen.
So, to clarify my point, I wouldn’t be surprised if Aderans and ICX have been delayed because the FDA is making them jump through many, many hoops due to objections raised by HT doc’s who don’t want Aderans or ICX to succeed.
There is good news, though. We can find out what objections the HT doc’s have been raising. The US’s Freedom of Information Act allows people to request information from federal agencies, and this includes the FDA. I think it would be best if many of us request info from the FDA regarding the Aderans and ICX trials since that would give us a better chance that we’ll get a response. If anyone is interested, please let me know.