Citron Comments on Inovio (INO) “Partial Clinical Hold”
Price Target Lowered to $2
Yesterday, Inovio announced a “partial clinical hold” from the FDA for its COVID-19 vaccine candidate INO-4800.
Below we explain why this announcement has caused Inovio to become Pinocchio.
The Normal Clinical Trials Process
Below is the timeline for a normal clinical trials process:
- A sponsor submits their investigational new drug application to the FDA
- The FDA has 30 days to respond
- If the FDA does not respond, the sponsor is free to proceed
- Alternatively, the FDA can respond by placing the proposed trial on a clinical hold
In the case of Inovio’s planned phase 2/3 clinical trial, the obvious question is:
“Why did the FDA order a clinical hold?”
Inovio mentions in their press release that:
- “The U.S. Food and Drug Administration (FDA) has notified the company it has additional questions about the company’s planned Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800, including its CELLECTRA® 2000 delivery device to be used in the trial”
We do not think this is the full story.
Inovio = Pinocchio
READ CITRON’S FULL COMMENTS HERE
