Last week, I ran a chart on the track record of Complete Response Letters versus approvals from the FDA, demonstrating that the latter is losing in favor of the former. Since then, the balance of power has changed even further.
To follow the action a bit more closely, I have uploaded a chart that I've made that provides a chronology of all CRLs that I notice. You will find the date of the announcement, the company, the compound, the indication, whether or not it is a drug or a biologic and a brief comment of reasoning from the FDA that may have been contained in the company's press release.
In addition, each of the company's are listed below with Google Finance profiles lined that will outline the stock performance for the day of the announcement to determine the impact on small and big companies alike. Naturally, the smaller the company, the greater the impact, with one company losing as much as 62% in a day of the value of a share of stock, and some companies recover quickly:
- Pain Therapeutics received CRL on December 11. Product Remoxy.
- Targanta received CRL on December 8. Product oritavancin.
- Genta received a CRL on December 2. Product Genasense.
- Medimmune (AZ parent) received CRL on December 1. Product motavizumab.
- J&J/Basilea get CRL on November 27. Product Ceftobiprole.
- Eisai received CRL on November 19 - stock not available. Product Banzel.
- On October 24, MediQuest Therapeutics received a CRL. Product Vascana. Noteworthy, this was a priority review. Stock not available.
- On October 20, AMAG Pharmaceuticals received a CRL. Product ferumoxytol.
- Abbott received a CRL on October 20. Product extended release hydrocodone with acetaminophin.
- Roche received a CRL on September 18. Product Actemra. Not available.
- Gilead received a CRL o n September 16. Interleukin.
- On September 15, FDA issued a CRL to Cephalon. Product Fentora.
- BioDelivery Sciences gets CRL on September 1. Product - Pain Patch.
- On August 26, J&J received a CRL. Product Paliperidone Palmitate.
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