Celsion Corporation (CLSN)

[RyGuy]

I think we are at that inflection point, where purchases here at this level could make new investors a lot of money.


https://www.insiderfinancial.com/is-now-the-right-time-to-catch-the-celsion-corporation-nasdaqclsn-knife/119722/

An IDMC recommended completion of the phase III at the end of last year, and we should see some data hit press during the second half of this year from the investigation. Concurrently, the phase I is ongoing, and translational data from the study is set for release at some point between now and the end of the second quarter.

Direct Regulatory filing in China could happen soon.

http://investor.celsion.com/releasedetail.cfm?releaseid=1004659

The Company recently met with the China Food and Drug Administration (CFDA) to discuss the ongoing Phase 3 OPTIMA program and regulatory pathway for ThermoDox in China. During the meeting, Celsion presented the final overall survival data from the Chinese patient cohort of the HEAT study, which demonstrated a survival benefit in patients treated with ThermoDox plus optimized RFA versus optimized RFA alone. The CFDA informed Celsion that if the ongoing Phase 3 OPTIMA trial is successful, the trial could serve as the basis for a direct regulatory filing in China without the need to file for prior approval in the U.S. or European Union which is currently required for foreign company application. This would allow the Company to accelerate its plans for a regulatory filing in China and, if approved, provide for a significantly earlier launch date in China than originally expected.