>>i think rprx is going to try and argue that the standard shouldn't apply to proellex given the holiday periods and fact endometrium is refreshed, particularly if they have a couple cycles to show there is no residual drug effect on biopsies during the drug-free interval..clinically this is reasonable, but its not clear to me the FDA will allow the company to forgo this current 2 year safety requirement, but i think rprx didn't want to be backed into a corner ahead of time with an SPA, but rather come to the FDA with some reassuring biopsy data in hand to negotiate this point
just a guess..<<
agree that this appears to be their strategy. what i don't understand is why you wouldn't take the opportunity to have these discussions with the FDA now and lock in agreement about drug holiday, need for 2 year safety data etc (in the form of a SPA) rather than spend 10s of millions of dollars of investors capital on trials and then know that you are going to have to have the discussions at the end prior to approval? talk about risk taking. i guess that sort of risk taking is fine when its somebody else's money.
>>one more thing. you and i and certainly the market would prefer if there was an SPA, even at a cost of a few months to negotiate and maybe 1 year in trial length to meet a more stringent safety hurdle, but lets not forget this is a real unmet need <<
yes, you and I and the market would prefer a SPA. but importantly i think any partner would also prefer a SPA! this 'no SPA' strategy of theirs may well have saved some time now but it may leave them in a financial crunch when partners shy away and they are forced to go the next 18mths alone.
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