Enzolytics Inc (ENZC)

[Wisdom of Locke]

Why be optimistic on ENZC?

Just one bit of IP - to review the ITV-1 drug and ENZC's history with the drug.

When a drug is approved by the EMA, after completing the Clinical Trials, ENZC would submit a validation order as part of the permitting process. Once the validation order is approved, then the EMA issues a PERMIT to sell the treatment in the countries accepting EMA approved drugs. Because there is a reciprocal agreement between the FDA and EMA the results of the clinical trials would be accepted by the FDA. Whether or not the FDA would issue permit to sell in the US, is up in the air. But with the EMA permit, most of the rest of the world will accept the treatment. Almost half of the worlds HIV cases are in Africa.

I have to believe that the purpose of the reciprocal treaty with the EMA was seamlessness - otherwise why have the treaty?

The concept of a “redo” is based on the following: The Bulgarian drug administration (under which the old trials were being conducted) joined the EMA after the validation order was produced for the old BDA clinical trial. It was not manufactured correctly in the US, which is why, in my opinion, the manufacturing has been moved to Bulgaria.

If the ITV-1 treatment passed for the BDA it only seems logical that it will pass the EMA.