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Acasti Pharma Inc ACST

Acasti Pharma Inc. is a Canada-based late-stage biopharma company with drug candidates addressing rare and orphan diseases. The Company is targeting three underserved orphan diseases: GTX-104, an intravenous infusion targeting subarachnoid hemorrhage (SAH), a rare and life-threatening medical emergency, in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull; GTX-102, an oral mucosal spray targeting ataxia-telangiectasia (A-T), a progressive, neurodegenerative genetic disease that primarily impacts children causing severe disability; and GTX-101, a topical spray, targeting postherpetic neuralgia, a persistent and often debilitating neuropathic pain caused by nerve damage from the varicella zoster virus (shingles). The Company’s clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection.


NDAQ:ACST - Post by User

Comment by lscfaon Jan 03, 2020 11:39am
104 Views
Post# 30515362

RE:Wow

RE:WowScumbag author still trying to mislead....

 
lscfa
 
Comments65 | Following
Co. actually said: 
But I think that clearly we may ultimately need to conduct an outcome trial but we believe that if our Phase 3 results can replicate our Trifecta Effect as we saw in Phase 2, we believe based on our discussions with key opinion leaders and high volume prescribers that CaPre could gain significant market traction without a cardiovascular trial and really become a preferred omega-3 for patients with severe hypertriglyceridemia or patients with broader cardiometabolic disease, again, even without outcome data.
02 Jan 2020, 12:44 PM Edit/DeleteReply0Like
 
Author’s reply »
 
I recall that statement from the conference call transcript, but I wasn't quite sure when those discussions took place and if it is outdated. The reason I say this is because if we refer to ACST's investor presentation (Oct 2019), slide 21, we see they have results from a KOL/High Volume Prescriber poll. The conclusion is that the majority of them would switch from Vascepa to CaPre based on treatment options.

 

Only problem is the fine print:

 

"Qualitative market research with Key Opinion Leaders (KOLs) and High Volume Prescribers (HVPs) conducted for Acasti in November, 2017 by Destum Partners, an independent market research firm."

 

It was done a year before the REDUCE-IT results came out, showing a significant cardiovascular effect. I'm uncertain if they are restating the outdated study, but if they are, then my feeling is that if they redo the study today, the outcome may be different.
03 Jan 2020, 01:11 AMReply0Like
 
lscfa
 
Comments65 | Following
The MD&A dated Nov 13, 2019 says:

 

We conduct market research at least annually with physicians and payers to monitor market developments, reimbursement and clinical practice.

 

This market research was updated in March 2019 to reflect the current views of physicians and third party payers following the publication of the REDUCE-IT study results. This updated primary qualitative market research project was conducted by Medical Marketing Economics, and the design of the study was similar to the Destum project, with one-on-one interviews lasting approximately 60 minutes in duration. These interviews were conducted with 10 physicians and 20 pharmacy directors, covering 179,913,005 commercial lives across the United States, consistent with the current payer mix for the OM3 market. CaPre was evaluated positively by physicians with particular value placed on its potential to lower TGs, LDL-C, and HbA1c (this was seen as unique, and especially valued), and to increase HDL-C, as well as its potentially superior tolerability features (e.g. easier to swallow when compared to the ethyl ester fish oils, and no fishy taste or "burpiness"). Importantly, since this research was conducted after the REDUCE-IT trial outcome results, the lack of clinical outcomes data for CaPre at launch was generally not seen as problematic for the majority of the physicians interviewed. On average, physicians indicated that they would begin prescribing CaPre 3 months after launch and would evaluate its performance in their initial patients after 3 to 6 months of use. Depending on favorable experience in initial use, some physicians indicated peak use could begin as quickly as 12 to 18 months after launch. Physicians expect CaPre to be priced similar to VASCEPA, and to have an out-of-pocket cost of approximately $10- $50. Payers also viewed CaPre favorably and did not anticipate any major reimbursement restrictions, with likely coverage at Tier 2 or 3 depending on the payer plan.
03 Jan 2020, 11:31 AM Edit/Delete

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