Replies to post #113476 on Biotech Values

[Cactus Quave]

I don't recall ever having a company announce a date when they will respond to the FDA

As I posted yesterday Post # 113339, SangStat issued PR in response to a Minor Deficiency letter in 1998. The language in that PR was in many cases identical to the Teva's PR on Tuesday. However, SangStat did speak to the type of information required by the FDA and they did actually say when they intended to respond (2-3 weeks). It was the only other PR I could find regarding a a Minor Deficiency letter.

[vinmantoo]

jb,

<I don't recall ever having a company announce a date when they will respond to the FDA upon making the announcement that they have received an FDA letter. >

So how many deficiency letters have you read, and more importantly, how many company responses have you read? We do know TEVA had no problem talking about specific dates when they expected approval as they mentioned August 2010 or that they would be disappointed if it didn't occur by the end of 2010. These precise timing expectations were given WITHOUT specific input from the FDA. Now TEVA gets a deficiency letter from the FDA and all they can say is they will respond in the near future. That is a change in tone.