Thursday, September 26, 2024 12:11:27 PM
Now, how does this patent-related stuff you're talking about relate to the success (or failure) by Helen to deliver on her promise of 3 new partnerships/deals during 2023 and here we are three-quarters through 2024 and still no deals? Biosectinvestor keeps harping on this shortcoming, with good reason.
Some of my recent posts have been theorizing on the cause(s) of this delay. I'm sure Helen's not real happy, either. I'm trying to think of reasons she may be delaying/dragging her heels. My conjecture is that she is doing so on the advice of legal counsel, with lawyers telling her that after detailed implementation regs come out (supposedly this fall) on the next phase of price negotiations with Medicare, the company's poker hand will be even stronger than it is now when it comes to negotiating royalty payments, especially if on the other side of the negotiating table sits a big fat international/global pharma company with a best-selling blockbuster monoclonal antibody on its hands and a juicy stream of US sales revenues it very much wants to protect and extend for as long as possible.
Of course, if we're being objective, this delay is also a gamble to the downside since the Biden administration greatly wants to reduce prescription drug costs. Consequently the new detailed implementation regs could very well contain wording that contradicts Helen's (and Merck's) thesis that converting an old IV drug to a subQ drug via co-formulation with hyaluronidase entitles that product to be called "new," thus preventing its maker from having to negotiate its price downward with CMS for an extended period of time. A recent letter to the editor in
(Sorry, due diligence is not always fun to hear.)
-- OJ
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