"Required to do a study" is different from "chose" to do a small study prior to PIII trials. At any rate, this is smart on Repros part.
1. The potential market is now much larger for the USA; despite any delay for a small study. (By default, if the Endocrine data from the last study is rock-solid, it is easy to imagine an unwelcome acquirer materializing due to the immense added value of just Androxal... with the free Proellex plus)
2. Repros WOULD NOT have gone into the meeting and offered up this compromise solution had they not been confident of the outcome of Endocrine endpoints.
3. Those posters who thought today's meeting would result in a final Pivotal design for Androxal don't understand the process; the meeting was to discuss and garner concensus between Repros and the FDA on what the design should be, not to walk out with a SPA in-hand and commence trials tomorrow.
4. I suspect Repros will design a trial very quickly. In essence, "no delay" because we will have the PII results for Endocrine quickly... in other words, we will know whether the PIII's will succeed before they start. So, yes, delay in getting NDA... but we will know the likelihood of success sooner.
5. EU partnership sooner than later.
On the whole, when further details emerge, I believe everyone will understand how valuable RPRX stock should be for the long-term.
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