Milestone

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anonymous

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Any details? Product looks like it fills a need, but company HQ in Canada (which means low pay and zero equity) with the US HQ in Charlotte? Any details on company benefits and culture?

They are recruiting me into medical affairs.
 


Drug has a unique delivery system and definitely fills a niche market. The question is how difficult will it be for the payers? Managed care and insurance coverage are more important now than they ever have been in the history of this business. The more difficult you make it on the physician and office staff, the less likely the drug will be prescribed. Fact.
 






anonymous said:
Was etripamil approved on March 27?
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CRL. And it looks significant. Impurities in the nitrosamine (new guidance) and an inspection of the new plant. Both occurred after the resubmission, were controllable and we should’ve been aware. We’re going to request a Type A meeting (urgent-ish) but in real world speak “your failure to prepare does not constitute a crisis on my part.”

This could be a problem
 




anonymous said:
CRL. And it looks significant. Impurities in the nitrosamine (new guidance) and an inspection of the new plant. Both occurred after the resubmission, were controllable and we should’ve been aware. We’re going to request a Type A meeting (urgent-ish) but in real world speak “your failure to prepare does not constitute a crisis on my part.”

This could be a problem
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So realistically, what is the timeline? I’m thinking 3 to 6 months.
 


HHS just cut their workforce by 25%. Total disarray. Drug approvals, especially one that’s been floating around for 22 years, are not going to be a priority.

They have to focus on undermining the measles vaccine, bringing back polio, and accelerating the bird flu into a human pandemic.

Priorities people!!!
 


anonymous said:
So realistically, what is the timeline? I’m thinking 3 to 6 months.
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Serious answer: early 2026 at best.

By the time we REQUEST our meeting, we need to have our responses finalized. (45-60 days)

FDA has to RESPOND in 30 days (30 days)
That puts us into early q3

Meeting within 90 days to agree on data SUBMISSION

We resubmit. Plus there still needs to be a plant visit and inspection due to the sale. ( HHS reshuffle is going to hamper that.)

Assume best case the data resubmission and plant inspection goes well we’re probably looking at minimum 3 month review, likely 6.

Probably late Q1 2026 approval assuming everything goes without a glitch. And we don’t run out of cash.

Don’t shoot the messenger
 


This is not a competent leadership team. The change impurities guidance and sale of a manufacturing plant mid approval process is pharm leadership 101. Some Of the potential reps who were being hired have been told it could be mid summer. That’s just lying
 








If you have spent any time on LinkedIn, you’ll see it was a bloodbath at FDA. Whether the division that approves our drug was impacted directly, or the individual reviewers themselves, or those responsible for deciding when to schedule follow ups to CRLs, or plant inspection's, the ripple effects of these cuts will be significant.

We all came here thinking this was our shot, but sadly it very likely will not happen any time soon. Our cash runway is short and wise investors take all this into account. Most likely scenario is the asset is sold to a company with cash, infrastructure and capabilities to carry it over the finish line. The ASSET will be sold, not the company. But even that will be for Pennie’s on the dollar. Too much risk. Our options will continue to be worthless as long as Milestone is an entity.
 




anonymous said:
No news is horrible news. Silence.
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Thank you for flying me all the way to Dallas and wasting my time. And thanks again for bombarding me again with nonsensical STAR questions over and over and over again so I can repeat myself. You idiots must really think that this job is something special. You’re not interviewing to be an FBI agent. Get a grip on yourselves.
 


anonymous said:
Thank you for flying me all the way to Dallas and wasting my time. And thanks again for bombarding me again with nonsensical STAR questions over and over and over again so I can repeat myself. You idiots must really think that this job is something special. You’re not interviewing to be an FBI agent. Get a grip on yourselves.
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You dodged a bullet. The VP of HR is a nightmare.
 




This drug will never see the light of day. Incompetent leaders with no plan to address the CRL issues, and the FDA has been gutted. No personnel or incentive to approve. Move along
 





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