drbio45, you wrote:
"You are completely mixed up, if MC-1 gets approved, and you think a hospital formulary is going to buy P5P from sources other than an FDA approved product manufacturer. If you try hard enough you can find generic lipitor in china or india"
No, I'm not. This isn't the same. There's no generic lipitor available in the US. There IS generic vitamin B6 available in the US and even if there were not, my point is that I don't see any barrier to someone making it, unlike the case with lipitor.
Vitamin B6 functions as a coenzyme in 100 enzymatic
reactions involved in the metabolism of amino acids,
carbohydrates, neurotransmitters, and lipids (1 ). Pyridoxine
(PN),5 pyridoxal (PL), pyridoxamine (PM), their phosphorylated
derivatives [pyridoxal 5 -phosphate (PLP) and
pyridoxamine 5 -phosphate (PMP)], and the end product
of vitamin B6 metabolism, 4-pyridoxic acid (4-PA), are the
major forms of vitamin B6 found in mammalian tissues
and body fluids (1 ).
In the diet, vitamin B6 is predominantly present in
three forms, PN, PM, and PL. After passive intestinal
absorption, the major part of the vitamin is delivered to
the liver and converted to PLP (2–4). PLP is available for
other cells only after being hydrolyzed to PL by alkaline
phosphatase, but most cells have pyridoxal kinase activity
and are therefore able to rephosphorylate PL to PLP (4, 5).
Most of the PL in excess of tissue requirements is oxidized
to 4-PA by the liver and excreted in the urine (4 ).
And you wrote:
"as far as thinking you can take enough b-6 to get enough P5P into your system to get enough of a dose to get the same efficacy as mc-1 you are mistaken. to take enough b-6 that would get you 250mg of P5P into your body would cause tremendous neurotoxicity and no doctor would prescribe it.
Unless you want to continue this further I don't think I have anything to add. This is the point board. IF you want to know the truth I have probably known about this company for 5 years and have made a lot of money on the stock. I can't believe what is happening to the price. they really screwed up the financing. The drug works"
See my response above. The MCU drug they call "MC-1" is just vitamin B6, a compound that's been around for decades and has no composition of matter patent. I see no substantive barrier to immediate generic competition (I also don't see why it would work).
If MCU has a successful phase 3 trial, which I don't think will happen, it will be sheer luck, as there's no mechanism known by which vitamin B6 would work. The company is based on phenomenology. It's tough enough to do drug discovery and development when the science is well-understood. MCU is just playing roulette and betting on 00.
And finally you said:
"The fact that two doses showed efficacy, and the FDA is accepting their phase 2 as a pivotal trial, reinforces that your last paragraph is written out of frustration with no knowlege of the facts"
Not at all. There are many companies who've done successful phase 1 and 2 trials, only to fail in phase 3. ALXN's CABG trials are a good example of this where the FDA also accepted a phase 2 trial as one of the pivotal trials, and there was much, much better pre-clinical and mechanistic data to support that, compared to vitamin B6. The fact that MCU's drug didn't dose-response is a worry.
If I were an MCU investor (I'm not), I'd ask the company how they plan to block generic competition should their drug be approved. "Use" patents often don't hold up so that wouldn't make me happy.
Happy Thanksgiving |
