Replies to post #113183 on Biotech Values

[HattieTheWitch]

...but I thought it was worth mentioning.

That could be the understatement of the millenium!

If you know, what were the issues the FDA raised, and how were they addressed?

Thank you.

[pollyvonwog]

What does this mean exactly?

[zipjet]

As DD suggests and as the PR stated the 2007 rejection as "not approvable" did not take the form of a "Minor Deficiency" letter.

That does not mean they may not be equivalent.

Without knowing the contents of the letter, we are pretty limited in what we can discern.

There are clearly possible outcomes that would lead to no approval for tL and for approval in the near future (a few months).

ij