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Results in supplemental studies with NN622 will indirectly prove appropriateness of our hypothesis.
No additional actions for Actos and TAK-559 will be required
[Pessimistic views]
Novo Nordisk will think another hypothesis different from ours.
Novo Nordisk will stop development of NN622 without clarification of possible mechanisms.
Novo Nordisk will use Actos as a positive control and get some contradictory results to ours.
There will be bladder tumors in a carcinogenicity study of TAK-$59 without any microcrystallines or
calculi.
The authorities including FDA/EMEA may require that we should reconsider our hypothesis in both of
Actos and TAK-559 based on Novo Nordisk's hypothesis or find other hypotheses.
In worst case, when Novo Nordisk will stop its development for this reason, the regulatory authorities
may not allow us to sell Actos or to continue clinical studies of TAK-559 until we can clarify the
mechanisms of the tumors.
[Other views]
Novo Nordisk expect the filing for approval to be delayed by close to 2 years. If only this tumor
issue does matter, 2 years until its NDA submission seem to be too long if it is set only for clarification
of the mechanism. Therefore, we may guess that NN622 might have other issues in clinical trials and
"urinary bladder tumor" is used just as a scapegoat or that Novo Nordisk virtually give up the
development.
2002/7/24 DSRL
Confidential - Subject to Protective Order
TAK-THOMCL-00019814
Produced in MDL on 09/14/12
Source: https://www.indup2298-00002ts.ucsf.edu/docs/zyjf0226

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