MSB to dispute FDA finding in Type A meeting, page-103

First 103 Last

Share
Profile

Follow
ddwn

12,519 Posts.

3391

02/10/20

18:18

Post #: 47820281
Share

Originally posted by dplane: ↑

Legally, there don't seem to be too many options for MSB.

There is a statutorily-prescribed dispute resolution mechanism for FDA decisions, and you have to follow it to the letter. Otherwise, no standing to sue.

So FDA issues CRL? MSB can respond to the CRL as dictated by statute, including via requesting a Type A meeting, reapplying, walking away, or trying to comply with the additional demands in the CRL.

I assume at SOME point, there will be a final decision that could be appealable to Court (likely, I suppose, after the further trial requested by the FDA was done, but the application was still not granted), but again, there may not be, so long as the FDA has STILL NOT rejected the application - only put forward FURTHER additional requirements to prove it works. Eventually, you would likely have an argument that it is acting unreasonably and you have a de facto rejection, but I don't think MSB is there quite yet (and may never be).

Remember, too, that the ODAC is only an "advisory" committee (it's right there in its name!), so the FDA does NOT have to abide by its decision one way or another, so I don't see a court forcing the FDA to do so, either.

Expand

Thanks @dplane - my question was more directed at the FDA (and not the CRL process per se).

Did the FDA have the capacity (legal, processes, mandate) of offering a conditional approval without going through the CRL or do they need to be asked via the CRL?
e.g. the FDA can only approve on what it was asked for (on the BLA) and nothing else - or do they have wiggle rooms via these discussions

BTW - how are you holding up?
LOL did you see that - by default (HODL)

Last edited by ddwn: 02/10/20

MSB Price at posting: $3.19 Sentiment: Buy Disclosure: Held
1 Upvote

1 Great analysis

Reply

Top Stories

PTR

Petratherm adds $1.6 to the piggybank ahead of SA titanium drilling program

ALR

Altair Minerals hits high-grade copper and gold at Wee MacGregor, QLD

WMG

Western Mines identifies 2 high-grade zones at Mulga Tank in WA

WR1

Winsome scoping study proposes low-cost operation for Adina lithium project

SNG

Siren Gold boosts antimony resource by 66% to 14.5Kt at Auld Creek, NZ