I expected we would have had an announcement about

I expected we would have had an announcement about the pre IND meeting by now. The delay is not necessarily due to IPIX; it could very well be the FDA. The election, Covid19 and recent holiday could push the time of the meeting back.

The FDA criteria for the IND listed by WSBC should be completed.

Dosage form, dosing schedule, formulation, and route of administration

- Known or suspected mechanism of action of the drug.

- Summary of the available pharmacokinetic information.

- Clinical information to support the proposed trial (see section IV.C., General Clinical
Considerations).


Much of the data was accumulated by the RBLs and it is possible the RBLs will not allow release of all the data until the pre print of the peer review journal article is released. The article should be released soon, any day now.

In any event I expect the pre IND and IND meeting will be completed with good results. The next steps should occur quickly after the IND.

Human Clinical study sites
Outline of clinical trial plans and protocols
CRO and probably a CDMO
Results of grant applied for by RBL
Additional preclinical studies ? animal studies like Regeneron

Other likely future events:
New hires
Additional funding
Better definition of Dr DeGrado's status and efforts
Outline of plans after the short initial human trials
Licensing or Partners

JMO

and my opinion is it all is going to progressively unfold and be completed by the 4th quarter 2020 and early 1st quarter 2021.

GLTA, Farre