Recent press and FDA statemen

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Anonymous

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Any thoughts as to when the FDA will reply?
Will KV make some statement soon?
Does our fate now lie totally with what the FDA will say?
Anybody care to shed some light here, the anticipation is killing me here
 






Let's wait n see what the FDA issues back after this fiasco.
Anything favorable towards Makena will literally sky rocket it's sales let alone it's severly depressed and discounted share price.
F## them politicians an what not, Makena is clearly the choice in terms of effectiveness and overall safety.
Hope to see them finally rip apart this compounded and unadulterated 17P formulations
 






Anonymous said:
Let's wait n see what the FDA issues back after this fiasco.
Anything favorable towards Makena will literally sky rocket it's sales let alone it's severly depressed and discounted share price.
F## them politicians an what not, Makena is clearly the choice in terms of effectiveness and overall safety.
Hope to see them finally rip apart this compounded and unadulterated 17P formulations
Click to expand...

Internally we were told not to expect a favorable response from the FDA because the FDA has egg on their face for approving Makena and allowing us to jack the price to the point where we could give away 30% free to the poor and still make it profitable for us. Now the states medicaids are not signing because the price is still to high so it will be atleast 6-12 months before the FDA makes a statemement about 17p. The FDA wants to see trends on 17p before making a decision. We may be BK before a decision is made.
 






Totally disagree, get your facts straight. Many physicians are question and now disclosing these recent findings to expected mothers.
FDA had started their investigation prior to the release issues. Read it carefully.
 






This is the way it will work:

You guys finally start getting some traction in early 2012.
Watson gets Prochieve approved, and prices it at a reasonable premium over other similar forms of PG.
That price is much lower than the new Makena price.
They use "cost effective" all the time in their pitch.
They show how much better that drug performs. Sure, not in the same patients as your lousy drug, but still.
Domination ensues.
 






From Yahoo forum, good read


FDA is now is heading back in the other direction and may well find reason to take action against some compounders. In response to data given last month to the agency by KV Pharma, the FDA is conducting an investigation into various samples that apparently raised concerns about the quality of the active pharmaceutical ingredients and compounded products.

In a statement, the FDA says that, #8220;according to the analysis #8230;there is variability in the purity and potency of both the bulk APIs and compounded hydroxyprogesterone caproate products that were tested. Although FDA has not validated or otherwise confirmed the analyses provided by KV, FDA has carefully reviewed the data and will conduct an on-site review of the laboratory analyses. FDA has begun its own sampling and analysis of compounded hydroxyprogesterone caproate products and the bulk APIs used to make them. That process is ongoing. #8221;

This research demonstrates important differences in product quality between FDA-approved Makena and these compounded 17P formulations. Healthcare providers and patients have no practical way of ensuring that compounded 17P formulations meet FDA ��s quality standards, #8221; Greg Divis, KV Pharma ceo and president, says in a statement.

We asked an FDA spokeswoman how many different compounders and compounded versions of Makena were being probed, but have not received a reply. We will update you if and when we do. We have also asked David Miller, executive director of the International Academy of Compounding Pharmacists, for a response and will update you accordingly.
Rating :
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It was over for Makena the day the price was announced.
If FDA takes away the dominant alternative of 17P compounded, that will help.
But only til Prochieve shows up.
Then it will be crushed.

Don't fall in love with that company car...
 






Won't the FDA takes months to examine the data? Even assuming the data is airtight, it makes more sense for the FDA to increase controls on compounded products rather than pull them from the market. This is a small win. The real key is what will Watson's price for Prochieve be. Doubt it will be higher.
 






Anonymous said:
Totally disagree, get your facts straight. Many physicians are question and now disclosing these recent findings to expected mothers.
FDA had started their investigation prior to the release issues. Read it carefully.
Click to expand...

This board is not polluted by a bunch of the psycho's from the yahoo board. They all bought when the shares were high and are now invading every board on the internet to try and change the story.

This place is still a disaster.
 






Anonymous said:
Won't the FDA takes months to examine the data? Even assuming the data is airtight, it makes more sense for the FDA to increase controls on compounded products rather than pull them from the market. This is a small win. The real key is what will Watson's price for Prochieve be. Doubt it will be higher.
Click to expand...

Watson will kill us. They are so big and have so many products they will just price Procheive at such a discount to Makena we will be positioned out of the market. We have no way to win here.
 












This company is, was, and always will be nothing but a bunch of drama. It is, was and still is a real life soap opera. The FDA won't ever approve anything except a book on how many lives were destroyed by selfish people that cared about themselves.
 


















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