Y nota de Jefferies sobre como afectará el shutdown a la FDA:
In the near term, operations/timelines are still generally ongoing (ie. over the next month), but if the shutdown continues (and drug user fees dry up in weeks), we will head into uncharted territory where reviews could come to a halt, resulting in a growing backlog.
Our expert cited the FDA is currently able to still partially work because they have user-fee money to work off of. While this is not a "huge amount," it has helped continue regulatory reviews and other workloads. A few important points: (1) Our experts estimate the agency would have roughly another month of runway; (2) Any items or submissions for which user fees have been paid prior to the shutdown (ie. prior to 12/22) can continue (hence near-term PDUFA dates are still active), and if any advisory committee meetings have been scheduled those will continue; (3) Submissions after 12/22 are in a queue (which is good) but generally would not be worked on until shutdown is resolved; (4) If shutdown continues beyond the foreseeable future, ie. ~1 month, then essentially many reviews will stop; (5) In that case only essential matters will continue to be worked on such as leadership oversight of FDA, food safety matters, product/manufacturing safety issues, or BTD, or Priority Review, etc., but these could still be impacted due to required CMC or other reviews that need to happen and limited by personnel.
Companies will want to get their filings in as soon as possible and in the queue. In the worst case scenario, if the shutdown continues and the agency has to halt all review processes and focus only on "essential matters," then we end up in "murky waters" as we will end up building a queue of submissions. According to our experts, the agency will have some algorithm of how they go through the queue with drugs/agents with priority review and/or other high need taking priority. It was clear in this case, companies with submissions later in the queue could get delayed. Our estimate is a PDUFA could get delayed by perhaps the length of time from when funds dry up (next month) to when the government is back open.
Companies that have made submissions prior to 12/22 will be earlier in the queue.
We highlight a few selected tickers that come to mind in terms of near-term filings that
can happen but PDUFAs would be riskier given the above info: SAGE (PDUFA 3/19), KPTI
(PDUFA 4/19), AMAG (PDUFA 6/23), DOVA (PDUFA 6/30), VRTX (triple pill filing soon),
AMRN (Vascepa sNDA filing March), ESPR (BA filing Q1), EPZM (Taz filing soon), IMMU
('132 re-submission), NVS (Mayzent), SNY (Cablivi), SNY/REGN (Dupi for Paeds), ROG
(Tecentriq for ES-SCLC).