I’m sure you read the guidance for Covid:
III. PRE-IND PROCESS
During the current public health emergency, with the large number of potential therapeutics for COVID-19 related illness, it is essential that the review process for investigational drugs be as efficient as possible. To facilitate this, we are urging sponsors to submit a pre-IND meeting request that allows early and thorough review and discussion between the sponsor and FDA, which can lead to more rapid review of the subsequent IND and assurance of subject safety, which in turn can facilitate faster clinical trial initiation for programs that proceed to that phase. Given the range in clinical manifestations of COVID-19 and the large number of drugs and mechanisms of action being evaluated for use in this disease, the Center for Drug Evaluation and Research (CDER) has established a multispecialty, multidisciplinary team focused on review of drug development proposals.
We recommend that sponsors seek initial advice under pre-IND meeting requests.5 For the purposes of our response to the COVID-19 public health emergency, we are consolidating the typical pre-IND meeting request and package development process into a single step. For pre- IND requests for drugs that treat or prevent COVID-19, the content requests and processes described within this guidance substitute for those used in other settings, which FDA has described in the draft guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (December 2017).
Etc.... if done right and quality data is given the turn around time will be much quicker than a normal pre-ind and ind process. I would not relate to previous trials. This is Covid.
