Big Update

So.. i met with Dr. Khine and Dr. Avner yesterday. We fixed up the consent the way the IRb wants, filled out the IND form as well as established a DSMC (which, as far as I understand it, is a committee that makes sure we are not doing anything horribly wrong. They are independent and not associated with the project. Ours consists of Dr. Racine, a CHAM doc who has background in statistics; Dr. Hafeez - a peds ED doc who is also their ethicist, and Dr. Vicencio, a pediatric pulmonologist.) Wrote up the cover letter for all this stuff - including the resubmission of documents to the IRB as well.
We also went to the pharmacy and spoke with a very nice pharmacist who was able to assisst us and tell us that we would indeed be able to get bottles with about 60mL of either Orapred or placebo, with only a number on the bottle. The idea is to store these things in the Pixis so they will re- stock them when they see they are running low.
Now, all that we are waiting for is for Dr. David to sign off on the project. Dr. Khien and Dr. Avner aren't so happy that this is a requirement as the project has already been approved by the IRB... but, it is one of the requirements they put. Dr. Avner emailed JD yesterday to try to get the ball rolling, since as of now, I am meeting with him next wednesday. I already gave him a copy of everything we submitted to IRB. Hopefully, this will go smoothly. The ER docs will be getting inserviced about our research next wednesday.. so hopefully we can get started soon thereafter.