former med student for equity research about pre-hire assignment

I'm supposed to make an analysis of whether three pending clinical trials will read positively or negatively. My background is science not finance. I was sent 10 attachments. The trials are in 2020-2022. The only relevant attachments that they sent thus far in my opinion were a written transcript of the chief medical officer at a conference going over how in previous clinical trials on record the drug outperformed the placebo, along with their associated slides in a separate presentation.

I found in my first slides of the presentation I am only trying to meld the transcript with the slides but I don't think I have any novel analysis.

I tried to go to PubMed to look for the trials but came away empty handed.

Can someone offer me advice. I really want this job and I have until the weekend only.

 
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Was just curious on how much scientific background you had since I would say your answer should vary based on whether you have more of a medical background or hard science background - you want to focus your pitch on things you can sound like an expert on since questions will arise if you discuss the write up with your analyst. Generally, I would first consider the mechanism of action and whether other similar assets have comparable pre-clinical data you can assess to read-through to probability of clinical success (I.e. how does it affect the target of interest pre-clinically and is that target a well-validated clinical target or completely novel; if it’s not completely novel maybe highlight what management has said previously about why their molecule is differentiated and is likely to have a) improved efficacy or b) improved safety). Next I would consider trial design and think about the bar they’ve set - are they evaluating the drug against an active comparator, to what extent are patients pre-treated, are there any factors that could increase efficacy of the active drug (stratify by bio marker status, only select high risk patients) or potentially contribute to outperformance by the comparator arm. Finally I would discuss what success means from a clinical and commercial context - what primary endpoints are they evaluating and what’s the significance of each in relation to the SoC and the current unmet need (I.e. is Adverse Event X a common feature of current drugs used to treat the disease or is there a high failure rate for a subgroup of patients).

 

How strong is the phase1/2 data?
Compare the pivotal with the previous trial design. What has been changed? Identify those risk factors? 
Any similar trials? Or other trials use a similar endpoint? How difficult to achieve clinical significance for the endpoint? Will it take longer than the period of the trial? Patient variability?…etc

of course you can discuss mechanism of action too.

They may ask you if positive, how much the data can move the stock price? But the answer really doesn’t matter…

 

How do I identify the risk factors for the new trials (your “pivotal” trial)? Also I think there’s an abstract at clinicaltrials.gov? for one study but the studies have not been published yet

It’s drug versus placebo 

 

The three pending studies are smaller sample size placebo-controlled crossover studies. I want to make something of the fact that they are smaller sample sizes going from 500 to 100 or 30.

I have to come up with a clear "yes" or "no" whether these trials will be successful do you have some thoughts?

The preclinical data is statistically significant compared to placebo.

 

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