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Saturday, January 20, 2018 9:01:37 AM
Again most of the hold ups are regulatory in nature and beyond control of IPCI. Maybe its our expectations that need to be adjusted
So we know PODRAS protocol is done which is big given the nature of it. Giving someone potentially lethal doses of drugs to prove you overdose tech works in no small feat. Think about it, who want's to be the one approve and allow that trial if it fails? So again the hold up on that is regulatory again. I wouldn't be surprised to see an update in the end of year report in Feb.
I'll admit that the Rexista HAP studies would've been nice to been further along. But given the FDA is dragging its ass again and has yet to provide the protocol is not fault of IPCI. The only pundits predicting 9 months for completion are the ones here. I haven't seen any reputable source say 9 months to do those studies. With them being confident they will resubmit in September I'd imagine they're ready to go as soon as they get the protocol to start. Plus the lawsuit being resolved in October delaying launch to 2019 only buys them more time to do all that's required and to make sure we can answer the questions of the stupid panel who goes off track.
So 2 ANDA's in first half and podras update? I think that's a good start to the year. Especially if those ANDAS are the other two in the MNK deal. It would resolve the cash burn problems and then with positive data on rexista would hopefully attract investors/licensee's.
I'm banking on significant news by end of February along the lines of Podras and ANDA's. If that happens I wouldn't be surprised to be back at $2+ which is why they're not concerned about Nasdaq delisting.
And again I'm going to stop saying this after this last time. A RS doesn't change much. It doesn't solve the problem because its a Market Cap problem.
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