Ann: Update on meeting with US FDA, page-29

You guys are far too focused on human trials.

It is time you really looked at what is required by the FDA and also look at previous Recce announcements.

Before human trials can start Recce must have been granted Investigational New Drug Status (IND). Recce used to talk about this but have lately dropped any reference to IND.

To obtain IND the FDA needs to be sure that the drug “Recce 327” has been subject to appropriate testing.

Appropriate testing involves the testing of the drug to be performed under GLP standards. See previous announcements a long time ago re schedule of tests. Recently did identify GLP tests it was going to do.

To date Recce have not released any data about it performing tests under GLP standards.

Why? Perhaps because these tests are very expensive and take a long time. Also I think that due to the real concern around existing antibiotics becoming less effective Recce were hoping for the FDA to lower their standards.

Obviously the meeting with the FDA reinforced the requirements of the FDA I.e. Recce needs to perform GLP tests. The results of these GLP tests together with other relevant information regarding the chemical characteristics of the drug, the drug production methodology will be the basis for Recce applying for IND status.

If Recce are awarded IND status they can then think about human trials.

The recent announcement says it will be several quarters before Recce can really look at human trials.

I think this means that Recce were told by the FDA they have a lot more tests to do (GLP tests)

If Recce hade done all the required tests of the FDA it would not take several quarters to get to the next step.

I think Recce’s announcements have been very vague.

We shareholders deserve a more detailed explanation of what is really happening!!!