SPPI.....down 21% per market!!

SPPI,...No FDA approval for Spectrum Pharma's CE-Melphalan NDA, CRL received; shares down 21% premarket 

Spectrum Pharmaceuticals (SPPI) receives a Complete Response Letter (CRL) from the FDA in response to its New Drug Application (NDA) seeking clearance for CE-Melphalan, branded as EVOMELA (melphalan). A CRL means that the agency cannot approve the application in its present form. 

The company neglects to specify the nature of the deficiencies only to state that there were none of a clinical nature. CEO Rajesh Shrotriya, M.D., says, "We will work swiftly with the FDA to address the Complete Response Letter. We remain committed to bringing EVOMELA to the market for patients and plan to work closely with the FDA."Shares are down 21% premarket on light volume.

所有跟帖： 

• 哎呀，老勃，出来解释一下 -满仓红- ♂ (0 bytes) () 10/23/2015 postreply 05:25:12

• 幸亏没有抱10块的期望去赌，没有跟。看来炒股水平有些提高。：-） -涨佬- ♂ (0 bytes) () 10/23/2015 postreply 05:26:43

• 药没批. -Liu_Huan- ♀ (0 bytes) () 10/23/2015 postreply 05:37:03

• 早讲了看见老印你要跑。 -yhr- ♀ (0 bytes) () 10/23/2015 postreply 05:42:34

• 可以抢个反弹今天?? -victor5241- ♂ (0 bytes) () 10/23/2015 postreply 05:58:27