An Orphan drug determination for CAB 102 shouldn't be far off but whether it happens in the next week or the next 2 months I can't say.
IND applicants don't have information to leak until FDA determination or request for further information is actually received however I see absolutely no reason as to why CAB 102 approval should not be forthcoming.
The Australian Government would not have co-funded the IND application on a one-for-one basis unless the Ts were crossed and the I's dotted. The body of research sitting behind MK Ab the application is extensive and studies done through the Westmead Centre are credible.
Most brokers, funds and so-called sophisticates and potential clinical development partners don't want to hear any of this. Most of these guys just care about getting sequential green ticks from the FDA.
Getting the first tick for IND approval will therefore place Cellmid on a map and something of a SP rise should follow.
Patient enrolment will herald a further increment the SP.
We know that the MK antibodies are safe but we no have to demonstrate it. My guess would be Early hints of meaningful efficacy could 3 bag the SP with another few bags coming at the 1b endpoint. Where it would go from here depends on the deal Cellmid would make with potential partners.
Partnerships could come earlier or later in the clinical trial journey. I sense an earlier partnership rather than a later one but it takes 2 to tango.
cheers
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