Arena Pharmaceuticals, Inc. (ARNA)

[BIDWACKIE]

Hi Clawmann, question regarding scheduling and to what Jack wants to submit to the F.D.A..If you don't mind, can you elaborate on the scheduling as to what you said and this person mentions.

Thanks



You mentioned this in your post:

<Right now the FDA has lorcaserin on Schedule IV, and - if that does not change - ARNA will have to go through a DEA licensing process that could take 4-6 months>


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The other post says:


Additionally, the FDA stated in the CRL that it would recommend placement of lorcaserin in Schedule IV of the Controlled Substance Act based on its review of the materials submitted in the NDA. The CRL provided the opportunity to complete preclinical studies that may lead to a different recommendation
what Jack said is that the FDA had recommended placement of lorc in Schedule IV which would require a DEA review of 4 to 6 months. But then he stated very clearly that Arena is in discussions with the FDA to have this changed.Arena submitted additional abuse liability study data and other data to the FDA as part of their CRL response. This was not an issue for the panel to address. This is an issue that as Jack again stated will be discussed with the FDA.