(Total Views: 583)
Posted On: 02/22/2021 4:04:53 PM
Post# of 155004
We haven't seen a therapeutic roll-out from this administration yet. Not to be political, but these people actually seem to think before they talk.
That's why I don't think past is prologue regarding companies touting results before the FDA is fully signed on. And there is a lot to sign on to - I could see a group re-reading the HIV BLA in detail right now - especially the safety and manufacturing sections. I could see an internal education program on the drug.
If feasible, I'm convinced this administration would want to have many issues, from patient prioritization to global allocation, worked out before any news went public.
The "material event" crew here says if trial results are clearly "not good," NP can't hide behind the FDA talks - the SEC won't let him. But, if results are good or great, does NP have the flexibility to say nothing, as he has?
In the merger world, you have to disclose entering into formal discussions and ending them. Otherwise, nothing other than a signed definitive agreement triggers an 8-K.
Is that why NP is using the phrasing he is eager to "conclude discussions" with the regulatory agencies? Trial results aren't determinative - only the FDA response on the path forward is.
Or this could be wishful thinking.
That's why I don't think past is prologue regarding companies touting results before the FDA is fully signed on. And there is a lot to sign on to - I could see a group re-reading the HIV BLA in detail right now - especially the safety and manufacturing sections. I could see an internal education program on the drug.
If feasible, I'm convinced this administration would want to have many issues, from patient prioritization to global allocation, worked out before any news went public.
The "material event" crew here says if trial results are clearly "not good," NP can't hide behind the FDA talks - the SEC won't let him. But, if results are good or great, does NP have the flexibility to say nothing, as he has?
In the merger world, you have to disclose entering into formal discussions and ending them. Otherwise, nothing other than a signed definitive agreement triggers an 8-K.
Is that why NP is using the phrasing he is eager to "conclude discussions" with the regulatory agencies? Trial results aren't determinative - only the FDA response on the path forward is.
Or this could be wishful thinking.
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