Replies to post #105972 on Biotech Values

[ThomasS]

MNTA: Aren't you relying on 4th-hand speculation (irt to one issue of many in the approval process, a serious flaw in itself) which is markedly worse than 4th-hand factual info?

[zipjet]

Like I said, I tried not to leave much wiggle room, but I do not know how exactly Ms. Chen put these questions to her Teva contact.

RR, I appreciate the effort. However, Franklin had it right:

“Believe none of what you hear and half of what you see.”

In this case we do not know how faithfully the question was presented, did not HEAR the answer and do not know how faithfully the answer was transmitted.

I have done a fair share of questioning and "hearing" in depositions/trial including witnesses who had something to hide.

I suspect most of those who post on this board have learned to look for clues in the gaps, omissions, wording and tone of statements and filings which can be more telling than the picture being sold.

ij

[randychub]

Rock - Have the analyst ask which of these sameness requirements the FDA has verified that TEVA has meet.

Randy


Table 1. Criteria Used for Sameness Determination of Enoxaparin Sodium

1. Equivalence of heparin source material and mode of depolymerization
2. Equivalence of physiochemical properties
3. Equivalence in disaccharide building blocks, fragment mapping, and sequence of oligosaccharide species
4. Equivalence in biological and biochemical assays
5. Equivalence of in vivo pharmacodynamic profile