Why is it so hard to communicate with you? Ignite 2 was a failure. Eravacycline cannot be considered for cUTI.
Of course eravacycline can be used for other indications? After Ignite 2, would use use it orally? Many questions to be answered.
The huge drop in TTPH stock price is a vote of not confidence.
At the very least, the oral med delivery method is questionable.
Also the failed P3 implies that one cannot rely on P2 trials as a trailblazer.
There is no reason to ditch the stock now since the horse is gone (extreme mixed metaphor). But to hope that post trial analysis will yield positive results is misplaced. A P3 trial is rigorous given its breadth. Some will find subpopulations where the drug worked. Fine, now you have a compromised label. In the example of EXPR, the situation got worse after the post trial analysis. Another example is AAVL who failed a P2 trial, though about it and abandoned the drug. This abandonment cut the stock price by 50% on top of a huge failed P2 haircut.
The antibiotic perhaps can be used elsewhere, but not in urinary tract infections.
You are aware that the failed trial was with an oral med. It is too much to believe that digestion had something to do with the failure? Or it could be the pathogen species in the urinary tract were not responsive to the antibiotic.
Know how it failed is academic. Reality is when the stock price drops.
The recent drop in price may be leaks of the P3 post mortem. The smart investors are leaving before the news hits.
Biotechs are cash burning machines. It's not uncommon for them to trade lower than cash.
Example: AAVL: Trading at $7.95 against a cash value of $11.00
TTPH can go lower than $5.00.
BTW, AAVL also had a recent failed clinical trial.
Many longs on this Board are hanging on for the post-trial analysis from TTPH. They hope to see if any hope remains for the iUTI label.
They should check out ESPR. Esperion recently bumbled through a P2 and yesterday announced a P3 trial. The stock is down to $25 from a high of $100.
I think TTPH's post-trial analysis will not cause a sell-off. But clearly the stock will not rise. There is no way to sugar coat this: TTPH failed the P3 trial. There is nothing good in this.
LOL! You think the FDA will allow TTPH to file an NDA on a failed study?
Let me make it simple: NFW! The FDA may suggest an alternative trial protocol but that is it. Dropping 80% should tell you something: The smart money has left town.
The stock seems to be forming a bottom.
I have reviewed the citations in your post and they do not provide me with any meaningful information on the FDA purported requirement for two P3 studies to support a registrational NDA application. You are correct that Cempra is also doing two P3 studies on their new antibiotic. But this does not mean it was driven by an FDA requirement.
The JAMA article you cited over 2:1 ratio of P3 studies to approved NDAs. From this you assumed most drugs require 2 P3 trials to attain approval. What you missed is that the FDA does not approve all NDAs; many Complete Response Letters are sent out.
Your interpretation of the FDA guidance document you cited is also mis-guided. Yes, one can read that the FDA wants to see two sources of data to support an NDA. What you failed to understand is that the fundamental legislation supporting the FDA requires “two” studies. But the FDA has interpreted the “two” to really mean “one” and other data that is from outside the clinical trial. In baseball, the pivot man in a double play does not really have to have his foot on second base, although that is called for in the rules. Why? It’s the way Baseball interprets the rules.
I can believe why scientists want more clinical studies. It’s a belt and suspenders approach. But there is not one investor in the world that will want to have two P3 studies done in order to file an NDA. It is not a stretch of imagination to conjecture that such a rule would reduce the level of innovation in this field. Perhaps this is why the FDA interpreted Congress’s wishes as they did.
If you teach your PhD candidates based on your post, you will develop researchers who are not friendly to investors. They will not be invited in to the Board room to present to the business types. This will limit their career potential.
"my logic here says is that an antibiotic that's often not effective is also an antibiotic that's not safe"
Do you know how wrong this statement is?
There will not be an Ignite 2a study to find out what went wrong. P3 trials are very expensive; no reason to go over old ground. Move on.
I don't think antibiotics are any different than any other drug in the eyes of the FDA. If a drug was found for Ebola (I know, it's a virus), do you think the FDA would wait for another P3 trial on another pathogen before approving for Ebola?
Family members are relieved if there is a doc who will try to save a dying relative. If you cannot see this, I cannot help you more.
Nurses know the difference between a reckless cowboy doc and one that is desperately trying to save a patient. Again, if you do not understand this I cannot help you.
A patient who presents with advancing sepsis has a poor prognosis. Some docs will accept the inevitable and follow the protocols. But there will be others who throw the hail Mary and use Eravacycline off label. The patient who is only hours away from dying cannot lose and may survive.
Medicine is not all about the lawyers. But it sometimes seems that way.
The CRO has the data and when the study is done, releases it to the company.
A CRO that releases data such that key executives at the sponsor lose money on stock sales will not be getting future business. Since the statistical manipulation at the end of the study can take some time, there is leeway in when the data is released. If good, the release is before known stock sale dates so that the execs benefit. If bad, delay the release until after the stock sale.
This is why CEO and others seem to always time their sales perfectly.
There are many posts on this Board that say the following: "TTPH needs to find out if the FDA will allow them to file an NDA based on IGNITE 1 only. The standard is that two completed P3 studies are needed before an NDA can be filed."
I believe this is an urban legend that got started somehow and morphed into a general belief. The FDA does not require two P3 completed studies for an NDA application. Even more preposterous is that IGNITE 1 and 2 were for different indications.
Probably more factually true is that TTPH decided to wait for IGNITE 2's results and then submit the NDA. This was a business decision as it more economical for the salesperson to have two FDA labels in his bag when he visits the hospital.
The legend failed also from logic: There is a huge demand for fresh antibiotics. Why would the FDA require two P3 studies which will only delay the introduction? FDA labels only restrict how companies can market their product. Doctors who have a morbidly infected patient can try Eravacycline off label since they do not answer to the FDA.
The referenced FDA guidance document applies to all drugs. It does cite the need for two studies. But is is ludicrous to think that these two studies are for different indications.
What I think happened is that the two trials requirement morphed into P1, P2, and P3 a pathway taken by most drugs.
I don't know why TTPH did not submit an NDA for IGNITE 1.
Where is it written that the FDA wants to see to P3 trials before they will approve an NDA? In addition, how do you write a label for an injectable and an oral med at the same time?
It seems to me that from a business point of view, TTPH wants eravacycline to have a broad label. It kills not only one but many species of bugs. They can fall back on IGNITE 1 and file for an injectable drug for complicated intra-abdominal infection. This is probably a small market.
Urinary infections are more prevalent; thus the IGNITE 2 trial (failed).
Here is the secret sauce that is driving the selling: if an antibiotic fails to work in one environment, it can fail in others.
Crecy's question is worthy and he is pounding his head because everyone provide answers to other questions.
Restated question: Did anybody have a stop in play on Wednesday at a price just lower than the market, say $38 ps? If so, did you get stopped out at $38 or at a much lower price? Were you saved?
In American style (vs. British style), puts can be assigned at any time before expiration.
Puts are a derivative instrument wherein the writer is obligated to buy shares at a certain price at the demand of the option holder. The obligation is through the option expiration date. The premium paid by the option holder to the writer is the consideration for this transaction. Think of it as house insurance; you pay premium to the insurance company for the right to have claims paid during the insured period.
Very rarely have I been assigned puts before expiration. If it happens I believe it is due to the closure of another derivative play. It is more common to be assigned calls.
Lawyers cannot bail investors out of everything. In most cases, they want to line the pockets with fees and don't really care how much investors get. In the case of RCPT, how can anyone prove that the Board did not get the best price for the company? There were 7 weeks between announcement and final merger. Were there any other bids? Did the Tender not garner 83% of all shares? There has to be some evidence that RCPT could have been sold for more. What is it?
I expect all class action lawsuits to be killed by the lawyers. They will not spend a dime on a wasted efforts.
Four days after tender? Very fast! Let's see how long it takes for the non-tendered shares to be liquidated.
While you wait for the RCPT money to go into your account, you can participate in the other biopharmas by selling naked puts. If you get assigned, you will have bought the stock at the strike price minus the premium. But you wanted to get into the stock anyway. To do this, you much have a fairly high trading level authority. If you are afraid that the target biopharma will rise too quickly, buy calls.