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Friday, 12/23/2016 9:22:04 AM

Friday, December 23, 2016 9:22:04 AM

Post# of 10489
Galena's new lead candidate, GALE-401, is an extended release version of a platelet reducer that has been FDA-approved for about 19 years. The company intends to develop its version for treatment of between 135,000 and 175,000 U.S. patients with essential thrombocythemia.

Galena intends to begin another trial designed to support an FDA submission in the second quarter, and investors will want look out for whether the Agency will allow its approval via a shortened pathway. Following a successful mid-stage study, GALE-401's odds of approval seem fairly solid. In fact, the company is hopeful it will be allowed to shorten the timeframe to commercialization, given that the immediate-release form of the candidate is a well-known entity, although I'd be surprised if the FDA is so accommodating.

Beyond GALE-401 and the troubled NeuVax program, the company has another candidate in clinical-stage development for ovarian and endometrial cancer. Given its currently minuscule market cap of around $22 million, success for any one of its candidates would lead to big gains.


About the summer Neuvax debacle:

Galena Biopharma has since defended the data by suggesting many of the observed tumors that showed up in the NeuVax group's X-rays weren't actually tumors, but residual swelling caused by NeuVax-stimulated immune attacks on malignant cells. While it might sound like a farfetched excuse, Galena isn't the first to document a similar phenomenon, termed pseudoprogression.


this gave investors real not pseudo depression for sure~

Is fact that Adam Fish-Eyes back bashing Galena and his minions and fellow traveler-shorters are re-posting his old "articles" a GOOD sign after all?

Honestly IDK, the management of Galena clearly gambled wrong and not just on Neuvax, but selling off all profitable products to fund the trials, clearly they believed in it full-blast.

But Adam Feuerstein/ Ole Fish Eyes is NOT a scientist, he works for Jim Cramer whose background is shorting stocks, and do we believe he isn't still?
Read more: http://www.fool.com/investing/2016/12/22/galena-biopharma-stock-has-fallen-93-in-2016-could.aspx#ixzz4TfeOoOWP

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