Innovation Pharmaceuticals Inc (IPIX)

[wsbc]

Yes, should've been submitted a month ago or more, but at least now it's in.

https://www.fda.gov/media/137927/download

...'We recommend that sponsors seek initial advice under pre-IND meeting requests.
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 preIND 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processes described within this guidance substitute for those used in other settings, which FDA has described in the draft guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products' (December 2017).

The sponsor should submit a pre-IND meeting request in accordance with the process outlined in section V., Additional Resources, below. For both CDER and CBER, the sponsor should submit the meeting request with any specific questions to FDA. The pre-IND meeting request will be reviewed and generally responded to as a written response only meeting. FDA’s review and advice for the pre-IND meeting request will be expedited and prioritized based upon the completeness of the submission and scientific merit. Following review of the pre-IND meeting request, FDA will work with the sponsor to help ensure that all necessary information has been submitted. This pre-IND review will help result in a more efficient review of the subsequent IND
submission

We recommend that all sponsors initiate COVID-19 drug development discussions under a pre-IND meeting request, instead of a pre-emergency use authorization (pre-EUA) request. Providing information in a pre-IND meeting request will generally facilitate a more efficient development process. If a drug is a good candidate for an EUA, initiating discussion under a pre-IND meeting request does not preclude submission of an EUA request to FDA in the future, if appropriate. However, at the time a sponsor initiates drug development discussions with FDA, there will generally be insufficient information to assess whether, or at what point, an EUA might be appropriate. While we are encouraged to see the rapid development of potential therapies for COVID-19, in most cases, the effectiveness of novel or repurposed therapies is unknown at the pre-IND stage. Authorization of drugs through the EUA mechanism involves an understanding that the known and potential benefits outweigh the known and potential risks of the drug for the diagnosis, treatment, or prevention of an appropriate disease or condition. In general, drugs being studied for treatment or prevention of COVID-19 have insufficient data for FDA to make such a determination. Accordingly, many drugs proposed for use under EUAs will more appropriately be the subject of INDs, with consideration regarding potential authorization under the EUA mechanism to follow as appropriate and warranted
as more information is available.

Meeting timeline: https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap#:~:text=Vaccines%20(ACTIV)%20Partnership-,What%20is%20CTAP%3F,they%20are%20helpful%20or%20harmful

Generally, the earliest a meeting can be requested to be held is the day after the response goal; 14 days for Type A meetings and 21 days for Type B and C meetings.

(this is all I can locate regarding the meeting, but I thought I read somewhere that it was 7-14 days currently for review. Trying to locate...

Do you guys have an idea...what date? Is it in weeks or months? Or it's a guessing game?
Technically this should have been done awhile ago..no? Sometimes in August? Someone on this MB had mentioned that we should have filed for an IND. What was CAUSE for this delay? What made them to wait this long to go for Pre-IND Meeting?

Innovation Pharmaceuticals Announces Pre-IND Meeting Request Granted by FDA for the Study of Brilacidin for the Treatment of COVID-19 ..