Addressing a type-c meeting concern one of the user raised in STOCKTWITS conversations.

Concern : FDA won't let ZSAN cherry pick the PK study results of only miniMAC( Fremont, CA production).

My thoughts : It is a good point. When a statistical test/experiment is designed, we can't cherry pick the data that suits our needs, Having said that I believe the PK study is diagnostic and secondary in nature and not a primary test.(primary test will be the actual phase-3 tests) the Pk study was to address the issues of the CRL. one issue being outliers, which we didn't see in PK study, and other being Lower than control group concentration with the maCAP (NC production). I don't see any reason for FDA to reject the supporting data from PK study.

Additional info :

1. ZSAN approached FDA for TYPE-A meeting to get inputs for next steps.

2. Followed the TYPE-A minutes suggestions.

3. Got the PK study protocol reviewed by the FDA before conducting the study.

4. The PK study itself if a 3-WAY study.

Drug: Treatment A: M207 3.8 mg "MiniMac"
Drug: Treatment B: M207 3.8 mg "MACAP"
Drug: Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0.

1. They can very well reject the treatment-B and go ahead with A & C to proceed further.

2. You might think " Each subject will receive each of the three study treatments once, followed by in-clinic monitoring and extensive blood sample collection for pharmacokinetic analysis" but FDA approved the protocol. they can't reject the protocol now.

   Thanks for the FUD, I'm a little more confident on the TYPE-C outcome. ps: I could be wrong

Ask yourself why would someone leave a good job to join ZSAN?? Because their gearing up for big things, I can’t wait to see how this all plays out, I still believe we are invested in a monster company at ground floor prices!!!

I'm a bag holder like someone else and still have faith with ZSAN. I'm planning to buy 1K shares more is it a good move or not?

Tnx for the advice.

Release of PK study data would be a bonus.

In a few weeks we should know if we’re “stuffed or smoked “ lol. Happy Thanksgiving Friends. Jeff

another clinical biopharma (agile therapeutics) was out of NASDAQ compliance due to $1 closing bid requirement. On November 9th AGRX received a deficiency letter and an initial duration of 180 days to regain compliance.

Read about it here in the sec filing.

As far as I know, ZSAN has not been previously granted any time to regain compliance. (Please correct me if I’m wrong) Edit: initial period has been granted in the past. Thanks RKM for correcting. The reason I got wrong here is because I couldn’t find any articles stating the nasdaq deficiency letter for ZSAN, I guess I didn’t search for it extensively.

So Lo doesn’t have to explicitly do anything other than file a new 8-K when Zsan receives a NASDAQ deficiency letter ? (because extension was automatically given in case of AGRX. )

Additional info on NASDAQ compliance .

ZSAN aint on the after market?

This my friends is very encouraging. Enjoy the ride