“You’ve got enough to get approved for children – go ahead and file, and then consider how to take the product into adults.’’
To make such a statement, one would assume you have already reviewed the data / information ..... I mean how else could any FDA representative(s) arrive at this conclusion ? Some might even wonder why the resubmission was needed at all in that case ? lol
As far as SI acting in a lone wolf capacity ... you would have to think that the company lawyers (and in addition, especially the PI insurance lawyers) would want to assess and approve any 'direct comments from the company or its authorised representative's when it relates to the same subject matter of the CA .... it would be ludicrous otherwise IMO
..... and where is the new Chair in all of this ? She would have to be aware of it surely so perhaps complicit in some way shape or form (IMO of course) ? It has certainly raised a few eyebrows and seems entirely out of character to antagonise the FDA but yet here we are
GLTAH
Australian newspaper article, page-95
-
- There are more pages in this discussion • 131 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Add MSB (ASX) to my watchlist
 (20min delay)
|
|||||
|
Last
$1.01 |
Change
0.030(3.06%) |
Mkt cap ! $1.153B | |||
| Open | High | Low | Value | Volume |
| $1.01 | $1.04 | 99.0¢ | $5.111M | 5.050M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 2 | 211966 | $1.01 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $1.02 | 136540 | 9 |
View Market Depth
| Last trade - 16.10pm 16/08/2024 (20 minute delay) ? |
| MSB (ASX) Chart |