RE:Relax Well, now that this process is back in TLTs court, they have December to knock out whatever answers are needed by the FDA. I think this is a matter of the beaurcracy not understanding and need to be taught. TLT will need to lead them by the hand until they understand. AND the FDA probably want it documented so anyone can understand it. This is TLTs first Ind for a Drug. These are Docs, Engineers writing how this will all work, needs to be 'dumbed down', lol IMO.
Oilminerdeluxe wrote: It is just a little delay with approvals. If the FDA wants answers, they will get them. In December not much happens, it will get done. Frustrating as it is to not have action in the US yet, wo do have it in Canada. 5 patients treated is nothing to sneeze at :-). And results are what will decide our fates. Being a hyper-neurotic person, I was not surprised something like this would happen. Not liking it, but it's like seeking an approval to drill for oil or metals in the ground, there is always some issue that needs to be addressed. Until we know otherwise, this is a just a tiny setback, albeit a frustrating one. But it will get resolved. By then, we will have t w o patients who have gotten their 3 month check up. Now that is exciting !!