Immune Pharmaceuticals Inc (NASDAQ:IMNP) announced yesterday that it had received feedback from the FDA concerning its lead asset program, an investigation of its drug Ceplene in combination with low dose IL-2 for the maintenance of remission in patients with Acute Myeloid Leukemia (AML).
This one’s an interesting one. Basically, the announcement was negative, but markets have regarded it as extremely positive. Well, negative is probably a little strong. It’s a step forward in the sense that the company knows what it needs to do to put together a protocol for the FDA that will get accepted, and once accepted, it’s got a clear path to a pivotal initiation. However, that the agency has come back with some recommendations and requirements suggests that the initial proposed trial had some deficiencies, and at core, this is a delay. Delays cost money, and at this end of the biotech space anything that costs more money that initially expected can be crippling.
We don’t expect the company to falter too much, and the phase III will almost certainly go ahead base don a solid protocol application, but there’s probably a near term correction on the cards for Immune Pharmaceuticals Inc (NASDAQ:IMNP) as markets reevaluate what we see as a bit of an overzealous response to the news.
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