Thought I'd ask if anyone was aware of how long prior to the FDA acceptance of the Fast Track designation. Should see a pop from the filing, but would expect acceptance of the designation to get things moving further as a measure of confirmation.
Although a significantly smaller mkt than CRPC, MTC will provide a measure of credibility, (not to mention income) and looks as though things are progressing in the CRPC arena as well. A good dual headlines day. Lets hope the overall mkt doesn't negatively impact/counter this significant event. Looks like we are starting the day in what is to be a down mkt.
Cheers to all longs.
What happened to today's gains? The headlines this morning for the stock were good, and with ASCO just a few days away I thought it would keep going up. Seemed like a good time to buy, and I bought at $4.78. I can't believe how quickly I'm down.
This is from the FDA that was given.
<A request for Priority Review must be made by the drug company. It does not affect the length of the clinical trial period. FDA determines within 45 days of the drug company’s request whether a Priority or Standard Review designation will be assigned. Designation of a drug as “Priority” does not alter the scientific/medical standard for approval or the quality of evidence necessary.>