Cassava Sciences Inc (SAVA)

[XenaLives]

This is just plain sad - our pay for play system needs a big overhaul.

This alone is reason for me to watch this stock. Lost track of it with the name change.

From the replied to post.

Pain Therapeutics Charges FDA With Lack of Transparency, Clarity in New Drug Application for Remoxy ER; Says Not Close to Approval - Shares Slide

2/5/19, 11:37 AM
11:37 AM EST, 02/05/2019 (MT Newswires) -- Pain Therapeutics (PTIE) reported Tuesday on the outcome of a meeting with the US Food and Drug Administration as it seeks approval for its new drug application for Remoxy ER, an extended-release gel formulation of oxycodone (CII) with physical/chemical properties intended to deter abuse.

The biopharmaceutical firm said during the meeting, the agency denied making math errors, material mistakes or misrepresentations during a June 2018 Advisory Committee Meeting. The company also learned it would need to invoke the Freedom of Information Act to access additional data generated by the regulator with Remoxy ER. The agency also argued Remoxy capsules lack abuse deterrence via the injection route of abuse because "oxycodone can be extracted from the product."

The company admitted after the FDA meeting, it is no closer to product approval than it was a year ago.

"We had hoped for a fair, neutral and impartial review of the Remoxy data. Instead, we walked out of this meeting feeling a bit disoriented by FDA's lack of transparency, clarity or helpfulness," said Pain Therapeutics CEO Remi Barbier. "It's a rare occasion when two parties can't agree on simple math. We can't work with shambolic regulations. This is not how you win support for innovation."

Shares of Pain Therapeutics are down 20% in early trading.

Price: 1.09, Change: -0.11, Percent Change: -9.17

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