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Ca.ceo105/30/2020 09:33

$Nabriva Doing that DD, figured out that their newest drug “CONTEPO” was actually already declared safe in its last NDA filing in April of 2019, the drugs NDA was denied from a logistics standpoint, and from facility inadiquicies, hence this quote from the CRL (FDA Complete Response Letter) “the FDA was unable to approve the NDA in its present form based on issues related to facility inspections and manufacturing deficiencies at one of the Company’s contract manufacturers.” But the most important factor of safety, wasnt compromised, hence this quote “it did not raise any concerns with regard to the safety of CONTEPO.” —- This drug is focused on Complicated UTI’s and is really going to help a lot of people! The only thing that makes me nervous is believing that their C-Suite (their executive’s) did their due diligence to ensure the logistical errors of the past arent repeated ! They do have a conference coming up however, and i’m sure they‘ll present on the new drug, and i’m sure if they’re going to do that, they’ve made sure they’ve got their ducks in a row this time ! Especially with this new institutional raising of capital, Which is likely due to them needing to support Contepo and its manufacturing, and distribution, as well as the salespeople who individually go to offices and sell the introvenous drug. I want to set a reasonable price target of 1.6, and that will all depend on how it performs on monday, hopefully by the time we have market close, we close at 1.00, for now though, have a great weekend !

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Mavrik501·05/30/2020 14:46

yes I have been trading this stock since then and it was going to 3.00 when it's was denied by Manufacturing problem. So yes the drug is good just need to pass the new manufacturing and FDA will give the approval

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Midlife Vices·05/30/2020 13:37

So they denied NDA over stupid stuff like Bottle/Packaging, Label and print discrepancies and weight of cotton in the bottle? smh. Im exhaggerating of course and quite sure this drug has great qualities if its rejection was more from aesthetics, than affects negative. Im certainly buying more Monday

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