We'll never know why TLD has been delayed from July, that's a fact, nor will we know why locking the trial was delayed, or any other delays. In general I believe it's all tied to the regulators, but I can't say which one with any certainty, or if it was all caused by one, or if two or more were involved. Even today, while many think that the company is waiting publication, can anyone be absolutely certain that the company isn't waiting for a regulators decision for some form of expedited approval before announcing TLD.
My point is that we can guess, but we'll never know for certain. When TLD is released, we may learn of a Journal publication, method of expedited approval, etc. and we can guess that it's what held up TLD, but we really won't know it's a fact.
Perhaps some day L.P., Dr. Liau, and others will decide to write a book about what's happened in the last 15 or so years, but I seriously doubt it. I've often thought a Biotech version of the Sting should have been made showing how in the development of Erbitux, BMY was stung into a multi-billion dollar partnership that ultimately resulted in Martha Steward and Sam Waksal the CEO of IMCL being jailed. After that case FDA rules were changed, but prior to that time a company could lie about what the FDA was saying, and the FDA's hands were tied about calling out the lie. The Sting was based on the FDA routinely telling IMCL that they had qualms with the clinical trials, but IMCL telling BMY that all was great with the FDA.
I believe we've had hints from the company about delays caused by regulators, but because of the IMCL case, if the company were to say anything that the FDA disagreed with, the FDA would be free to speak out about it. Companies rarely speak about anything they're doing with the FDA or other regulators, so while we can guess that delays have been caused by the regulators, almost no company will ever say so, and the regulators will only speak if a company has lied about what they've done, or said.
Every day we're one day closer to when we'll learn about the trial, that's about as positive as we can be. Will it come in the next 5 days, or 100 days, no one will actually say. When it happens, have no doubt, we'll know it.
Gary
