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hptaxis

01/25/11 3:28 PM

#113203 RE: TripleCutter #113202

Link, please. [Thanks for the post. TEVA does not change their stripes! But, thanks to TEVA for the buying opportunity.]
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momentum74

01/25/11 3:40 PM

#113205 RE: TripleCutter #113202

Bought some here 12.43 -21% scaling in for a bounce
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dewophile

01/25/11 9:15 PM

#113296 RE: TripleCutter #113202

Indeed, for truly simple issues, the FDA has created a telephone amendment pathway



i'm glad wedbush picked up on this point. from the FDA regs:

D. When is an amendment classified as a telephone amendment?3
If an amendment would otherwise be classified as minor, but the deficiencies are of a
limited number or complexity, it can be classified as a telephone amendment
(i.e. so the deficiencies in TEVA's application are NOT liminted in number or complexity)

it goes on to give some examples:

Such deficiencies include:
1. Clarification of data already submitted
2. Request for a postapproval commitment
3. Final resolution of technical issues, such as finalization of specifications