Re: MNTA – M118 lead indication
>Discussed why they went after elective PCI PIIa trial first: Prove that cath-lab safety is etched in granite before proceeding to medical-management clinical studies.<
To my knowledge, this was the first time MNTA explained the rationale for the switch in the M118 lead indication from ACS to stable angina/PCI. Craig Wheeler’s remark (above) makes a good deal of sense, but it may be tough for some readers of this board to parse. Let me try to make it as simple as possible.
When a patient with Acute Coronary Syndrome (ACS) presents at a hospital with symptoms that suggest an MI, the first order of business is determining if the situation warrants: i) open surgery; ii) PCI (a stent placement in the cath lab); or iii) treatment with drugs only (“medical management”).
It may be desirable to administer an anticoagulant immediately—before it is even determined which of the above subgroups a patient falls into. Therefore, for clinicians to be comfortable with giving an experimental drug such as M118 during the ACS intake period, they must be confident that the drug is suitable for all of the subgroups described above.
It follows that, from an ethical and practical standpoint, testing M118 in PCI is a prerequisite for testing it in the ACS-intake setting. MNTA presumably came to this realization after speaking with cardiologists who told the company they would not participate in an M118 trial in ACS until MNTA completed a successful trial in PCI.
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