I would appreciate if anyone would share their thoughts or examples regarding the approval process for Spontan.
I have been unable to find any drugs that have changed method of delivery and been approved only on a bioequivalence study. If you can find examples of this, please let me know as I would love to add to my research.
I am of the belief that LTR Pharma will be requested to run a phase 2 trail at the bare minimum. The FDA will want a longer term study of patients that suffer from ED. I assume a study of roughly 6 months with endpoints related to short / long term side effects, efficacy and overall effectiveness. LTR must be aware of this. Why else would they randomly raise circa 24 million ?
LTP Price at posting:
52.0¢ Sentiment: None Disclosure: Not Held
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