Deny and Delay, page-4

Thinking about it I also tend to agree wcamp, the FDA likely does have a real concern and while it is not at all improbable that they may have other agendas they certainly would not want to be behind a drug that proves to do more harm than good especially given evidence to that effect was provided, albeit a dog study at very high dosages (my understanding)

As for the EMA, certainly it doesn't hurt to play one off against the other, the Europeans may enjoy an opportunity to one up their American cousins That said the EMA will have to consider carefully the partial clinical hold in the states and I am sure the FDA when making their decision would have been well aware that approval in Europe may raise questions about their PCH decision.

As for the EMA being our knight in shining armour I am reminded of another biotech I am into FTT (aka TIS)
Not so long ago FTT then TIS was looking very good until ego's out EMA way were bruised (my opinion) and suddenly what was a device became a medicine and extensive new testing was required leading to the destruction of millions of dollars of inventory re a product that was shown to work. Back then our thread was the inverse of this one, "Lose the EMA and head for the FDA, they are much better" lol...
Mgt were fired, TIS became FTT and we are now back with the EMA playing better politics which seems to be what it is really all about.

all my opinion, I continue to hold and hope, TIS are back on track maybe this one will be soon to