Some posters are out there claiming to be do good things for investors and potential investors. Nobody can predict the future with certainty, so there is always a lowering of expectations, hard work and objectivity that goes in to being a trusted source for information. Who do we trust versus who do we toss aside (or add to the ignore list)? The key is to not allow any one to dictate your decisions with money. You have that final say, and that should be empowering enough.
This is yet another post by Pagiantmetknicksfan. This poster keeps close tabs on the ELTP pipeline, and for a post that originated on April Fool's Day, it holds up well against anything any ELTP basher has advocated. Here's pagiant's post:
2nd Quarter Expectations
This is yet another post by Pagiantmetknicksfan. This poster keeps close tabs on the ELTP pipeline, and for a post that originated on April Fool's Day, it holds up well against anything any ELTP basher has advocated. Here's pagiant's post:
2nd Quarter Expectations
Naltrexone approval and launch – We learned that in November, Elite
received the same supplemental approval requirement for change of
facility as Hydromorphone. Thus the delay. Inspections occurred in
August – Should be approved 2nd quarter
Predicted 4th TAGI ANDA approval and Launch – Inspections also in August. 6 months is typical for approval. We are 8-9 months. Expecting to see it 2nd quarter 2012. As noted by the CEO, ANDAs are taking longer and longer.
I predicted patent news saying that is was “very very close”– Both of the Eli patents were rejected. However, regarding Eli 216, Elite has submitted amended claims on 3/30 based on discussion with the patent examiner. The patent examiner stated that the results are unexpected (ie not obvious) so Elite’s argument is very strong. The rejection was that the argument cited ranges which were not represented in the claim. The claims have been resubmitted with these items removed. Again, this was based on Elite's discussion with the patent examiner. Elite has requested a quick approval as the USPTO basically agrees that the results were “unexpected”.
Eli 154 patent is not going to be pursued further. Elite stated they feel it is not worth the expense and will rely on their IP. They have a partner willing to fund half but still need the other half. Note that their tech in ELI 216 is also for the extended release.
Epics 1st of 8 Elite products - Transfer began some time ago but based on the current FDA timelines, it could be a quarter or two before approval. Up to the FDA.
HITK - 100m generic - I thought we might see news on this and I think we have. Look at the R&D revenues we saw in the previous Q and expected this Q.
Actavis drugs – The tech is undergoing transfer to Elite for contract mfg. This began quite a while ago. Since it is contract mfg and an approved product, I am hoping to see these products in Q2. Isradipine is the one to watch with a huge worldwide market and few competitors.
Lodrane extended products – The e-mail I received from ECR stated that they are hopeful to have the products back on the shelf towards the end of the year. The FDA requested add'l data. This puts NDA approval sometime 3rd Q to have the products out 4th Q, but you never know.
New Items
$5m funding through Socius. Will we see a tranche delivered for this money? I think this is for Eli 216 trials and that will likely be the trigger.
Deal with a Hong Kong Pharma for end to end development of an NDA – We don’t know what the milestones will be but I suspect there is some right at the front to pay for ramp up costs.
Cash Flow Positive – Pretty obvious. Elite ran ~500k in the red last quarter with just Phantermine, new Lodrane just launched and R&D. The CFO noted that that R&D revenue was on the same impressive pace as the previous Q. The NJEDT program gave Elite ~500k. This makes them cash flow positive by itself. Add in the revenues for contract mfg of Methadone which started this Q and launch of Hydromorphone.
Profitability – This is likely to be very close because of the addition of Hydromorphone and Methadone and continued growth of the existing TAGI products. If we can Launch Naltrexone, and/or a couple more products Elite should be able to hit profit. The big key for me here is the HK NDA development deal. Instant cash
New Epic deal – Could be big, could be just BAU type stuff
Update on Eli 216 studies, PH3 plans - ???
Add'l Mikah – More products added to their website and the statement that Elite will be making their leading products. I believe most of these were discont'd from Actavis Totowa NJ.
Elite's second facility coming online...
Predicted 4th TAGI ANDA approval and Launch – Inspections also in August. 6 months is typical for approval. We are 8-9 months. Expecting to see it 2nd quarter 2012. As noted by the CEO, ANDAs are taking longer and longer.
I predicted patent news saying that is was “very very close”– Both of the Eli patents were rejected. However, regarding Eli 216, Elite has submitted amended claims on 3/30 based on discussion with the patent examiner. The patent examiner stated that the results are unexpected (ie not obvious) so Elite’s argument is very strong. The rejection was that the argument cited ranges which were not represented in the claim. The claims have been resubmitted with these items removed. Again, this was based on Elite's discussion with the patent examiner. Elite has requested a quick approval as the USPTO basically agrees that the results were “unexpected”.
Eli 154 patent is not going to be pursued further. Elite stated they feel it is not worth the expense and will rely on their IP. They have a partner willing to fund half but still need the other half. Note that their tech in ELI 216 is also for the extended release.
Epics 1st of 8 Elite products - Transfer began some time ago but based on the current FDA timelines, it could be a quarter or two before approval. Up to the FDA.
HITK - 100m generic - I thought we might see news on this and I think we have. Look at the R&D revenues we saw in the previous Q and expected this Q.
Actavis drugs – The tech is undergoing transfer to Elite for contract mfg. This began quite a while ago. Since it is contract mfg and an approved product, I am hoping to see these products in Q2. Isradipine is the one to watch with a huge worldwide market and few competitors.
Lodrane extended products – The e-mail I received from ECR stated that they are hopeful to have the products back on the shelf towards the end of the year. The FDA requested add'l data. This puts NDA approval sometime 3rd Q to have the products out 4th Q, but you never know.
New Items
$5m funding through Socius. Will we see a tranche delivered for this money? I think this is for Eli 216 trials and that will likely be the trigger.
Deal with a Hong Kong Pharma for end to end development of an NDA – We don’t know what the milestones will be but I suspect there is some right at the front to pay for ramp up costs.
Cash Flow Positive – Pretty obvious. Elite ran ~500k in the red last quarter with just Phantermine, new Lodrane just launched and R&D. The CFO noted that that R&D revenue was on the same impressive pace as the previous Q. The NJEDT program gave Elite ~500k. This makes them cash flow positive by itself. Add in the revenues for contract mfg of Methadone which started this Q and launch of Hydromorphone.
Profitability – This is likely to be very close because of the addition of Hydromorphone and Methadone and continued growth of the existing TAGI products. If we can Launch Naltrexone, and/or a couple more products Elite should be able to hit profit. The big key for me here is the HK NDA development deal. Instant cash
New Epic deal – Could be big, could be just BAU type stuff
Update on Eli 216 studies, PH3 plans - ???
Add'l Mikah – More products added to their website and the statement that Elite will be making their leading products. I believe most of these were discont'd from Actavis Totowa NJ.
Elite's second facility coming online...
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