FDA indicated that they will provide feedback to Tenax as to whether a levosimendan NDA for treatment of coronary bypass surgery patients at risk of LCOS is fileable
following their review of the requested information.
I can't put my finger on precisely what the difference is, but it was clear we had a fileable
And why cut out and paste up little slips of fast-yellowing paper, when you can get lovely, laser printed, fileable
copies made in an instant?
likely be fileable
under the Indian Tucker Act as applied through the
Also available are fileable
forms for various elections, such as Election to Carryback Casualty Loss, Election to Forego NOL Carryback, and Election to Accrue Real Property Taxes.
In the new format, plan sponsors have the option of printing fileable
forms, as well as submitting questions or changes online to The Principal from the Principal Sponsor Service Center.
They also wanted to create fileable
business tax returns using the client information stored in a client write-up program, as well as create planning forecasts.
Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for RETAANE(R) depot as fileable
and has confirmed a priority review assignment.
That leaves us about five and a half hours to make a decision on the filing policies, whether the case is fileable
, create discovery packets, file a petition and deliver it to the clerk's office," said Deputy District Attorney Laura Foland-Priver.
The date that the FDA deems a PMA submission fileable
marks the continuance of a 180-day period, which began Jan.
Once deemed fileable
, the review of the clinical data will begin and the Company will work with the Agency to answer any queries prior to the FDA's determination of the need for a panel meeting.
It is also a major achievement for Xillix to be granted a fileable
status on its first submission.