FDA and Makena

[Anonymous]

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm249025.htm


well, this is quite a mixed message

 

[Anonymous]

and is the agency checking if the compounding is safe?

 

[Anonymous]

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm249025.htm


well, this is quite a mixed message

Not really. They are saying KV had no business threatening pharmacies with what what the FDA may or may not do. And what's more, because KV was so presumptious, they've forced the FDA's hand into publicly declaring they WON'T take enforrcement action against the pharmacies!

Whoever came up with that strategy at KV has cost the company hundereds of millions of lost Makena dollars and should be shot (publicly)!

 

[Anonymous]

But if the agency granted the rights to a substance , wouldnt they go with what they granted , vs a possibly non compliant drug?

Not really. They are saying KV had no business threatening pharmacies with what what the FDA may or may not do. And what's more, because KV was so presumptious, they've forced the FDA's hand into publicly declaring they WON'T take enforrcement action against the pharmacies!

Whoever came up with that strategy at KV has cost the company hundereds of millions of lost Makena dollars and should be shot (publicly)!

 

[Anonymous]

But if the agency granted the rights to a substance , wouldnt they go with what they granted , vs a possibly non compliant drug?

Usually yes. But KV (specifically GD) decided to take the law into their own hands and make claims about what the FDA would do to compounding pharmacies if they didn't cease and desist. Funnily enough, FDA didn't like that much and now, on principle won't do anything about the compounders. Ha ha. It's a fair bet the FDA won't be approving any more of KV's generics either! Ha ha again. And well done GD!

 

[Anonymous]

But if the agency granted the rights to a substance , wouldnt they go with what they granted , vs a possibly non compliant drug?

Let me guess. You were stupid enough to buy this stock and now see you made a big mistake. You should have read up on this pit before you bought.

 

[Anonymous]

Not really. They are saying KV had no business threatening pharmacies with what what the FDA may or may not do. And what's more, because KV was so presumptious, they've forced the FDA's hand into publicly declaring they WON'T take enforrcement action against the pharmacies!

Whoever came up with that strategy at KV has cost the company hundereds of millions of lost Makena dollars and should be shot (publicly)!

All Godeke.

 

[Anonymous]

Goedeke and the enitre marketing department should be fired for this mess. Greg should be looking to fire SG and this group or he should be fired by the BOD. The Makena launch is so screwed up we will never make it.

 

[Anonymous]

So far, this is looking like a disaster.

 

[Anonymous]

So far, this is looking like a disaster.

Fantastic!!!