22nd Century Group Inc (XXII)

[Justfactsmam]

If iQOS and VLN approvals are tied at the hip...(done together)...it appears that you might expect approval sometime in the "summer" when iQOS goes in for approval (expected by industry pundits) irrespective of non-binding advisory committees rejection:

"What's Next
“We still think FDA will ultimately approve the PMTA as soon as next month and MRTP later in the summer for IQOS,” Miller said in a note.
Piper Jaffray agreed, noting that the regulatory body does not appear to present insurmountable roadblocks.
“While the FDA's TPSAC (scientific committee) meeting has yet to conclude, we consider its strongly favorable vote on one potential modified risk claim to be positive,” analyst Michael Lavery said in a midday note. “... We believe this vote gives the FDA the open door it needs to approve a modified risk claim for IQOS, which we believe it is still likely to do.”
The FDA would need to renew any approval it grants to IQOS, which renders its impending ruling impermanent and is seen to lower the probability of rejection.
Lavery also anticipates a favorable FDA ruling on marketing authorization."