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d******8
发帖数: 1972 | 1 Somaxon (S
Shares of Somaxon Pharmaceuticals Inc. (NASDAQ: SOMX), a specialty
pharmaceutical company, opened sharply higher in today’s trading after the
company announced FDA feedback on the over-the-counter (OTC) development
program for Silenor®.
At last check, Somaxon shares were trading 25% higher at $1.
Somaxon said that in a recent meeting with the FDA, which was also attended
by Silenor partner Procter & Gamble (NYSE: PG), the agency provided clinical
and regulatory guidance that offers a clear path toward an OTC version of
Silenor.
The company believes that the FDA’s feedback offers a chance to develop an
OTC label that is tailored to Silenor’s clinical profile and is different
from other OTC sleep products.
Somaxon also announced some changes to its commercial team promoting Silenor
for the treatment of insomnia. The company said that it altered its Co-
Promotion Agreement with Procter & Gamble following which Procter & Gamble’
s exclusive negotiation period relating to OTC rights to Silenor is extended
from 60 to 120 days. The company also appointed Michael Allen as senior
vice president for Sales and Marketing, replacing Jeff Raser.
Richard W. Pascoe, president and CEO of Silenor, said that the company’s
first year of marketing Silenor provided it with a host of learnings
relating to the market and the most efficient use of its resources to
promote Silenor for the treatment of insomnia.
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Read more: http://www.beaconequity.com/somaxon-somx-shares-spike-on-fda-feedback-2011-10-04/#ixzz1ZunZTs2IOMX) Shares spike on FDA Feedback |
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