Replies to post #107839 on Biotech Values

[palindromy]

I agree in so far as the meaning of his statement is concerned. Even if he did not say FDA confirmed, we confirmed (with the FDA) is more than implied.

However, I think the main issue is the usual one with the FDA. Every sponsor always comes away thinking the FDA agreed with them about something or the other. Sometimes, the FDA even puts it down on paper(SPA). Teva wont be the first or the last to find out that what they think the FDA meant wasnt really what they really thought, or even more simply they just changed their mind.

[tinkershaw]

I don't see any confusion or obfuscation in Schlomo's statement... it's very straight forward:

Actually, the statement is not straight-forward. Either the language was specifically and carefully chosen, or he was just speaking off the cuff and was not so precise with his language.

From the cynical (and usual Teva approach) the language really says nothing about what the FDA thinks of the application. Instead it says what TEVA thinks of their drug, and their inference as to why it is now moving to OBP.

From the usual conversational perspective, we would assume he is talking about the FDA told us we have achieved chemical sameness, so were done here, just need to move it on for immunogencity to OBP and then we are good.

Again, if the drug is only now being examined for immunogenicity, why was it not being examined for this long ago? Momenta's drug was well over a year ago. If you look at the evidence, Teva is not straight-shooting but rather talking from the hip to keep up the optimism and progress being made.

But that is where it is at, and all we can do is parse and interpret and look at all the evidence. We cannot really know at this point in time, we can just suspect.

Did Teva actually repeat that statement word for word? If so, then it is likely an intentional use of wording.

The question needs to be posed to them "Did the FDA specifically tell you that your lovenox drug has been found by the FDA to be chemically the same so that it is ready for approval once the immunogencity issues are examined or is that a conclusion that you have come to on your own from other evidence, and if so, what other evidence?"

A compound question, which should be broken into two questions, but that is really what needs to be asked to clarify this issue.

Tinker

[zipjet]

I am with you up to this:

I don't know from personal knowledge the answer to that question, but from what I've seen looking in from the outside, would doubt.

IF you mean, that you do not think FDA is going to tell an applicant that "yes you have established sameness" then I agree with that. It offers too much legal risk to go making pronouncements before the final decision. Clerks do not need that.

Did I get that right?