FDA Fast-Tracked Drug From Company That Acting FDA Commissioner Founded; Restore Public Trust Files Suit

WASHINGTON — Following news that G1 Therapeutics’ drug has been fast tracked a second time since it’s founder Ned Sharpless took the reigns as Acting Commissioner of the Food and Drug Administration (FDA), Restore Public Trust filed suit in federal court today. The lawsuit filed by the public interest watchdog seeks to force disclosure of documents regarding Sharpless’ contact with G1 Therapeutics including potential meetings and phone calls. 

Ned Sharpless helped found the biotech company before he assumed his role as Acting Commissioner of the FDA and once held millions in stock. In the eleven years since its founding in 2008, G1 Therapeutics has never commercialized a single drug or made a single dollar in commercial revenue. But in five months with Sharpless as Acting FDA Commissioner, they’ve seen their lead drug candidate rapidly accelerate toward approval – twice – thanks to positive feedback from the federal agency their founder now leads.  

“Something very swampy is going on at FDA and Americans deserve to know the extent to which FDA Commissioner Sharpless worked to assist his former company in fast-tracking their drug, potentially using his position to enrich himself and his friends,” said Kyle Herrig, Senior Advisor to Restore Public Trust. “A small company’s stock soared after being fast-tracked twice by the FDA, which their founder now heads, and now they are stonewalling us instead of fulfilling their legal obligations to make the documents public. This is exactly the kind of insider politics that Americans are sick of – and they deserve to know the truth.”

In December 2018, G1’s stock plummeted after its cancer drug Trilaciclib failed to outperform placebo in a phase 2 clinical trial. 

On April 29, G1 Therapeutics announced that they received positive feedback from meetings with the FDA over their lead drug candidate, Trilaciclib, a drug that the company estimates could bring in over $3 billion annually if approved. The feedback was so good, in fact, that they were going to take the rare step of skipping the onerous and expensive Phase 3 testing of the drug altogether and start the FDA approval process. Brimming with new-found confidence, G1 also announced they were planning on expanding their workforce to prepare for commercialization of Trilaciclib. 

G1 Therapeutics’ confidence following the meetings with the FDA was so extraordinary, a Raymond James analyst questioned the executives on a conference call as to why they were so “extremely confident” that the FDA would approve Trilaciclib without further testing. The company responded that their confidence was warranted because the FDA explicitly told them that their next step should be to file for approval and that further testing was never even mentioned in the FDA feedback.  

On August 7, G1 Therapeutics announced that Trilaciclib was granted breakthrough therapy designation by the FDA, further expediting the development and review of the drug. Just one day after the most recent news, G1 Therapeutics stock rose over 26%.

In total, in the five months after Sharpless was named to his post, G1 Therapeutics has gone up 60%.

  • March 12, 2019: G1 Therapeutics Stock Closed At $16.70 Per Share. [Yahoo Finance]
  • May 10, 2019: G1 Therapeutics Stock Closed At $25.02 Per Share. [Yahoo Finance]
  • August 8, 2019: G1 Therapeutics Stock Closed At $29.76 Per Share. [Yahoo Finance]

RPT submitted multiple records requests to the FDA regarding the matter, and it has not received any of the requested documents to date of filing the lawsuit.

See the lawsuit at this link.


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