If you are directing your post to me. . . None
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Posted On: 06/29/2017 3:43:54 PM
Re: someconcerns #35407
If you are directing your post to me. . .
None of my posts addressed post NDA costs. These were IMO reasonable estimates for a solid, NDA worthy phase 3 on any of the indications.
That should scare nobody. Leo already laid out the requirements for B-ABSSSI. It will not be significantly different for any other phase 3. Check out phase 3 costs for a comparable oral drug double-blind dual arm (placebo, single dose) trial. Ballpark? Fill in your own number then.
Hence, let's land a deal to take these drugs into late stage. Good strategy when candidates show strong phase 2 results, as they likely will.
It ain't complicated. It shouldn't be controversial. It's not bashing. It's not pumping. It's opinion.
Secondly, few microcap biotechs plan on taking the product to market themselves. While a rare few have been successful, going alone is generally not the objective, as the skill-set and infrastructure would need to be acquired. That said, a pharma deal should be more advantageous to the biotech the later in development the drug resides. NDA submittals take work but an FDA approved drug should clearly garner considerably more than a promising pre-clinical or phase 1/2 . So while it also means investors see a greater long-term share of the revenue stream it may require equity financing to get there.
Instead, IPIX is shooting to have a deal shortly, on a mid-stage candidate. Lower risk and in-line with their development and financial runway.
None of my posts addressed post NDA costs. These were IMO reasonable estimates for a solid, NDA worthy phase 3 on any of the indications.
That should scare nobody. Leo already laid out the requirements for B-ABSSSI. It will not be significantly different for any other phase 3. Check out phase 3 costs for a comparable oral drug double-blind dual arm (placebo, single dose) trial. Ballpark? Fill in your own number then.
Hence, let's land a deal to take these drugs into late stage. Good strategy when candidates show strong phase 2 results, as they likely will.
It ain't complicated. It shouldn't be controversial. It's not bashing. It's not pumping. It's opinion.
Secondly, few microcap biotechs plan on taking the product to market themselves. While a rare few have been successful, going alone is generally not the objective, as the skill-set and infrastructure would need to be acquired. That said, a pharma deal should be more advantageous to the biotech the later in development the drug resides. NDA submittals take work but an FDA approved drug should clearly garner considerably more than a promising pre-clinical or phase 1/2 . So while it also means investors see a greater long-term share of the revenue stream it may require equity financing to get there.
Instead, IPIX is shooting to have a deal shortly, on a mid-stage candidate. Lower risk and in-line with their development and financial runway.
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