The Stockhouse Bullboard for Calgary-based biotech firm Stem Cell Therapeutics (TSX: V.SSS, Stock Forum) was buzzing Thursday, as posters commented on the day’s trading and news that the U.S. Food and Drug Administration has provided a verbal confirmation to remove the clinical hold placed on the company’s NTx(R)-265 Phase IIb stroke trial last September.
On the company’s Bullboard, the most posted board on Stockhouse Thursday, FoxTek1 said: “…FDA HAS REMOVED THE HOLD! And that is what has held this down so it's time to start a new chapter folks[sic].”
foz1971 also noted: “…The fundamentals for this company have been cited here many times and they are still strong, in fact they have improved by leaps and bounds with the latest news. And we will get this formally in writing (perhaps some will wait on this before buying). WE are heading up. Can't stop progress[sic]”
The company says the removal of the clinical hold will allow it to start the recruitment of patients under an amended protocol using NTx(R)-265 for the company's Phase IIb clinical trial treating acute ischemic stroke.
In a news release last September, Stem Cell Therapeutics said the change in clinical status came as a result of data from an unrelated foreign clinical trial in stroke using EPO which showed a safety concern that was being reviewed by the FDA.
"We are very pleased that our series of collaborative meetings with the FDA has resulted in this positive development. We are expecting to receive written notification from the FDA in the near future following which we will finalize the plans for our stroke trial," said Alan Moore, the company’s president and CEO.
With over 16 million shares traded Thursday, shares of Stem Cell Therapeutics gained three cents or 50% to trade at nine cents.