Innocoll Holdings PLC (NASDAQ: INNL)
Innocoll Holdings is having an incredibly strong start to the trading session today. After announcing that it has received important information from the United States Food and Drug Administration. As a result, investors got excited, sending the stock upward and prompting our partners at Trade Ideas to send us the alert. At the moment (9:37), INNL is trading at $1.56 per share after a gain of $0.48 per share or 44.01% thus far today.
INNL Announces Regulatory Pathway
As mentioned above, INNL is having an incredibly strong start to the trading session today after announcing that it has received the formal Type A Meeting minutes from the US FDA surrounding its New Drug Application for XARACOLL. In the press release, INNL had the following to offer…
“Innocoll received a Refusal to File (RTF) Letter from the FDA in December 2016 pertaining to the XARACOLL NDA initially submitted on October 31, 2016. In the RTF letter, the FDA indicated among other things, that XARACOLL should be characterized as a drug/device combination, which would require that the Company submit additional information. During the Type A meeting, representatives of the FDA, after reviewing information provided by Innocoll to address matters raised in the RTF letter, provided guidance which was confirmed in the formal FDA meeting minutes. The minutes serve as the official record of the FDA response to our proposal to address certain issues raised in the RTF by conducting an additional short-term pharmacokinetic study and several short-term non-clinical toxicology and biocompatibility studies. Innocoll believes, if adequately financed and successful, such studies may be completed in time for a resubmission of the NDA at the end of 2017. Data from these studies, along with additional manufacturing information required to address the new combination product designation and other chemistry, manufacturing and control (CMC) issues, are expected to be included in the resubmission. The acceptability of this data and other data that we reviewed with FDA during the meeting will be evaluated by the FDA during its review of the resubmission.”
What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on INNL. In particular, we’re interested in following the company through the resubmission of the XARACOLL NDA. Nonetheless, we’ll continue to follow the story and bring you the news as it breaks.
What Do You Think?
Where do you think INNL is headed? Join the discussion in the comments below or on StockTwits!
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