Given that most of the relevant data from the company was contained in the press release and the slides on ACUS website, the real meat in the CC was contained in the Q&A... Become a Complete Fool
The first questioner was Andrew Forman of Ham fame...
how is the FDA going to view the data from the two separate trials?
Is this the kind of data that will alter your practice?
MD says the answer is yes (I concur). Regulatory agencies look for accuracy... more than either sensitivity or specificity. Accuracy trumps all... it is the primary data point.
Is this an approvable data set?
Olberg... we can't speak for the FDA... again, the most important endpoint is accuracy which was hit in both trials. The decision will be made on the totality of the data. We think we have everything we need to gain approval. This advice is coming from very experienced people...
If you have significant disease, Nuke picks it up 61% of the time. Imagify picked up 74% of positive tests.
[This really is an important consideration. When we do a screening test, we're not very worried about false positives but we sure don't want to let a patient with coronary artery disease (a false negative) go home.]
How are the images read? [dumb question] Of course, the MD's read them.
The ultrasound machines are really nice [woo hoo]
How about a training packet?
We will provide the FDA with a training plan and package.
Could the FDA ask for another trial? [of course they could]
We think we have it covered. We do NOT have any plans for another trial on stress testing. We do have other trials in the works for new indications [one of these will be in the emergency room assessment of patients with acute chest pain and this application is actually the one that excites me the most. There's no good competing imaging modality in this area other than going straight to cath]
Ian Sanderson (Cowan)
Any discussions ahead of these trials with folks at the FDA?
The FDA is very aware of the design considerations in these trials. The FDA wanted to see angiography in as many patients as possible... the reason for the second trial. The FDA is aware of the tradeoffs in design and "they're OK with that". In total, the two trials are a good approach: trial one- lower risk folks, trial two- higher risk.
What were "changes in FDA criteria" that excluded 80 odd patients from the trial?
The original trials were designed such that RAMP I was a specificity trial only and RAMP II was designed as sensitivity only [I find this a hugely important point and one that I had missed up to this explanation]
The agency understands that those trials were set up this way. Those 80 patients did not have an acceptable nuke test which then excluded them from the new study design.
Could this test be a good compliment to NUKE?
Alan Symore (sp)
?? Expound on the adverse events?
There really are no adverse events with nuke.
There was a "very low" incidence of adverse events. Some local events. All "well tolerated". [I thought this was a useless answer to an important question]
Can Imagify be used with a physical stress test?
Yes, and we plan on doing trials with exercise instead of pharmacologic stress testing
Is there a way to read for higher specificity or for higher sensitivity?
Yes, there is a way to "titrate" results as long as we don't sacrifice accuracy.
Is the training a big deal?
Peter Boom (MLM partners)
How about the variability of readers?
Was the variation across readers reduced in RAMP II?
We demonstrated that reader training was reduced in RAMP II
The variability in readers should not be an issue with the FDA accepting the trials for NDA review
1- Again, I found it hugely important to remember the study designs. RAMP I was specifically designed to demonstrate specificity and it did. RAMP II was specifically designed to test for sensitivity and it passed with flying colors. That was the original purpose of the tandem study designs. They worked. It was only on into the studies that the FDA asked for other data. BOTH STUDIES DEMONSTRATED EXACTLY WHAT THEY WERE DESIGNED TO DEMONSTRATE.
2- Both trials got it on the accuracy.
3- They have a guy on the team (the ex-Genzyme guy) who has been involved in 31 drug approvals. They are comfortable with their preparation for NDA.
4- I found today's price action most interesting. While there was some recovery in the price... if you just x out the odd runup in price that started on 4/9... ACUS is just marginally above where it was at the beginning of the month. If you'd have just gone on vacation for the last three weeks only and arrived home today... you'd think "oh well, nothing much happened... we're through RAMP II and on to NDA."
Is ACUS worth buying today or tomorrow? I'd say it's a vastly safer bet today than it was 6 months ago. Do I wish I'd sold on the 17th? You bet I do.
What am I going to do now? I'm going to sit back, relax, and enjoy baseball season.
TANGENTIAL BIG LESSON... when you see un-natural moves in volatile gnat cap prices, do not assume somebody "knows something". Just tend to lighten into unnatural strength and buy into unnatural weakness (witness last December's action.)
Good luck guys (and forgive spelling.)
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Given that most of the relevant data from the company was contained in the press release and the slides on ACUS website, the real meat in the CC was contained in the Q&A...