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Re: Umibe5690 post# 213067

Wednesday, 02/06/2019 8:10:40 AM

Wednesday, February 06, 2019 8:10:40 AM

Post# of 732184
Umibe5690, just to try to balance the discussion on mfg change or not:

Do you agree something appears to be different with the final 108 pts?

If so, what do you think caused the improved patient response?

I don't know any more than anyone else here. But, if the final 108 pts performed the same as all others there is no question worthy of any time. But, if they did perform better there is reason to at least conjecture. I have tried to explain before, though it may not be worth much more time, that the word change has deeper meaning in pharma mfg. There are levels of change and a subtle change can be explained away as no change because the technical assessment concluded no need to do much to test for comparability due to level of risk to safety, quality or efficacy. So, my only point here is that when you expect LG to be able to explain everything when he is legally/competitively/regulatorily not permitted to say anything, your expectations are misplaced. I once heard a CEO respond to a question in a companywide meeting that nothing was underfoot to sell the company and the next day a merger was announced. Is he a liar, of course not, he just could not speak until the following day along with the announcement because it was not a publicly announced strategy. I would not consider LG's comments as gospel regarding this point. If he responded that he cannot talk to the question all would believe there was a change of some sort, so, there are questions he has to respond with a negative, at least for now, and, I would go one step further and state that we will probably never know what occurred here because with this product mfg is definitely a competitive advantage, one to be maximum protected. Enough said.
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