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Friday, September 21, 2018 12:05:54 PM
1 If positive it will take a while to get the FDA to approved revised labeling and what company is going to do that? This is a study not supported by a company and they are the bodies that ordinarily purse FDA for labeling
Many drugs are prescribed off-label every day.
2. If the results are positive and published, doctors could prescribe but no company can promote with the previously mentioned labeling.
That's what Michael J. Fox Foundation will do.
3. The implications are that if a prescription is written for a generic, it wil be filled by the pharmacy by the then available generic, and that is likely to be the low cost alternative (ie, NOT elite)
Demand goes up, supply goes down, market price increases. If STEADY-PD yields positive results, the current price being charged by the two current manufacturers will be totally irrelevant.
4. If the market explodes as predicted then you the bps will come back in a heartbeat.
No doubt about it. That means there will be a total of 4 competitors, which is still awesome for what will be a high-demand drug. Also, generic manufacturers frequently try to get the first ANDA filed so that they can get 6 months of generic exclusivity. This shows how even a few months head start is critically important. I'll take any advantage we can get.
Call on God but row away from the rocks.
-Hunter S. Thompson
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